FDA event 74466 · Recall Observatory

drug · product 1 of 88

B-COMPLEX #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 2ML Vials, MEDAUS PHARMACY

D-1167-2016

Recall number: D-1167-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151228-28, BUD: 06/25/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 2 of 88

B-COMPLEX #3 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 10ML Vials, MEDAUS PHARMACY

D-1168-2016

Recall number: D-1168-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 380 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160115-3, BUD: 06/11/16; Lot #: 160202-10, BUD: 06/11/16; Lot #: 160204-43, BUD: 06/11/16; Lot #: 160223-3, BUD: 06/11/16; Lot #: 160307-26, BUD: 06/11/16; Lot #: 160309-1, BUD: 06/11/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 3 of 88

B-COMPLEX (LIEBERMAN) IN NACL 0.9% (PF), B1-12.5MG, B2-5-PO4-10MG, B3-12.5MG, B5-12.5MG, B6-12.5MG/ML, 2ML Vials, MEDAUS PHARMACY

D-1169-2016

Recall number: D-1169-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 60 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151229-15, BUD: 06/26/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 4 of 88

B-COMPLEX WITHOUT B12 (PF) IN NACL 0.9%, B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY

D-1170-2016

Recall number: D-1170-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 4000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 151130-66, BUD: 05/28/16; Lot #: 160222-51, BUD: 08/20/16. b) Lot #: 151130-60, BUD: 05/28/16; Lot #: 160222-51, BUD: 08/20/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 5 of 88

B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

D-1171-2016

Recall number: D-1171-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 955 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 151222-11, BUD: 05/28/16; Lot #: 151224-5, BUD: 05/28/16; Lot #: 160111-1, BUD: 05/28/16; Lot #: 160119-3, BUD: 05/28/16; Lot #: 160119-64, BUD: 05/28/16; Lot #: 160217-10, BUD: 05/28/16; Lot #: 160307-22, BUD: 05/28/16. b) Lot #: 151223-30, BUD: 05/28/16; Lot #: 151224-2, BUD: 05/28/16; Lot #: 160111-1, BUD: 05/28/16; Lot #: 160112-2, BUD: 05/28/16; Lot #: 160118-2, BUD: 05/28/16; Lot #: 160119-64, BUD: 05/28/16; Lot #: 160125-1, BUD: 05/28/16; Lot #: 160208-4, BUD: 05/28/16; Lot #: 160210-64, BUD: 05/28/16; Lot #: 160215-6, BUD: 05/28/16; Lot #: 160222-14, BUD: 05/28/16; Lot #: 160307-22, BUD: 05/28/16; Lot #: 160307-23, BUD: 06/11/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 6 of 88

B-COMPLEX 50 IN NACL 0.9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 2ML Vials, MEDAUS PHARMACY

D-1172-2016

Recall number: D-1172-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160218-57, BUD: 08/16/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 7 of 88

B-COMPLEX 50 IN NACL 0.9% W/PRES., (BENZYL ETOH 2%), B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 10ML Vials, MEDAUS PHARMACY

D-1173-2016

Recall number: D-1173-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 4000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151220-4, BUD: 06/17/16; Lot #: 160216-31, BUD: 08/14/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 8 of 88

B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML Vials, b) 5MLVials, c) 10ML Vials, MEDAUS PHARMACY

D-1174-2016

Recall number: D-1174-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 62 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160209-24, BUD: 05/28/16. b) Lot #: 160106-12, BUD: 05/28/16; Lot #: 160222-70, BUD: 05/28/16. c) Lot #: 160129-9, BUD: 05/28/16; Lot #: 160202-16, BUD: 05/28/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 9 of 88

B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, LIDOCAINE 1%, METHYL B12 1MG/ML, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY

D-1175-2016

Recall number: D-1175-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 370 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 151228-62, BUD: 06/25/16. b) Lot #: 160111-2, BUD: 06/11/16; Lot #: 160113-3, BUD: 06/11/16; Lot #: 160113-76, BUD: 06/11/16; Lot #: 160118-1, BUD: 06/11/16; Lot #: 160119-2, BUD: 06/11/16; Lot #: 160119-65, BUD: 06/11/16; Lot #: 160122-9, BUD: 06/11/16; Lot #: 160128-10, BUD: 06/11/16; Lot #: 160202-65, BUD: 06/11/16; Lot #: 160204-44, BUD: 06/11/16; Lot #: 160217-54, BUD: 06/11/16; Lot #: 160223-5, BUD: 06/11/16; Lot #: 160224-66, BUD: 06/11/16; Lot #: 160229-23, BUD: 06/11/16; Lot #: 160315-3, BUD: 06/11/16. c) Lot #: 160118-1, BUD: 06/11/16; Lot #: 160127-2, BUD: 06/11/16; Lot #: 160210-37, BUD: 06/11/16; Lot #: 160223-5, BUD: 06/11/16; Lot #: 160310-14, BUD: 06/11/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 10 of 88

CALCIUM SODIUM EDTA 300MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

D-1176-2016

Recall number: D-1176-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 8500 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot # : 151123-11, BUD: 05/21/16; Lot #: 160105-24, BUD: 07/03/16; Lot #: 160118-7, BUD: 07/16/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 11 of 88

CESIUM CHLORIDE 600MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

D-1177-2016

Recall number: D-1177-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 506 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151207-10, BUD: 06/04/16; Lot #: 151222-18, BUD: 06/19/16; Lot #: 151222-20, BUD: 06/19/16; Lot #: 160210-47, BUD: 08/29/16; Lot #: 160210-49, BUD: 08/29/16; Lot #: 160215-20, BUD: 08/13/16; Lot #: 160302-45, BUD: 08/29/16; Lot #: 160302-56, BUD: 08/29/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 12 of 88

DEXPANTHENOL 250MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY

D-1178-2016

Recall number: D-1178-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 3500 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 151217-31, BUD: 06/14/16. b) Lot #: 151217-31, BUD: 06/14/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 13 of 88

DEXPANTHENOL 250MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY

D-1179-2016

Recall number: D-1179-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1110 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160204-45, BUD: 06/14/16; Lot #: 160210-38, BUD: 06/14/16; Lot #: 160215-9, BUD: 06/14/16; Lot #: 160222-16, BUD: 06/14/16; Lot #: 160223-6, BUD: 06/14/16; Lot #: 160229-74, BUD: 06/14/16; Lot #: 160302-31, BUD: 06/14/16; Lot #: 160307-27, BUD: 06/14/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 14 of 88

DMPS 50MG/ML (PF), 5ML Vials, MEDAUS PHARMACY

D-1180-2016

Recall number: D-1180-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151216-33, BUD: 06/13/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 15 of 88

DMSO 99.9 (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

D-1181-2016

Recall number: D-1181-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 2218 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 151217-2, BUD: 05/30/16; Lot #: 160115-6, BUD: 05/30/16; Lot #: 160303-8, BUD: 08/30/16; Lot #: 160303-10, BUD: 08/30/16. b) Lot #: 151203-37, BUD: 05/30/16; Lot #: 151203-72, BUD: 05/30/16; Lot #: 151209-7, BUD: 05/30/16; Lot #: 151209-8, BUD: 05/30/16; Lot #: 151209-9, BUD: 05/30/16; Lot #: 151209-10, BUD: 05/30/16; Lot #: 151209-11, BUD: 05/30/16; Lot #: 151209-13, BUD: 05/30/16; Lot #: 151209-14, BUD: 05/30/16; Lot #: 160104-31, BUD: 05/30/16; Lot #: 160113-77, BUD: 05/30/16; Lot #: 151218-7, BUD: 06/15/16; Lot #: 151218-8, BUD: 06/15/16; Lot #: 160113-78, BUD: 07/11/16; Lot #: 160113-4, BUD: 07/11/16; Lot #: 160122-10, BUD: 07/20/16; Lot #: 160201-6, BUD: 07/30/16; Lot #: 160201-7, BUD: 07/30/16; Lot #: 160204-9, BUD: 08/02/16; Lot #: 160208-5, BUD: 08/06/16; Lot #: 160208-6, BUD: 08/06/16; Lot #: 160210-65, BUD: 08/08/16; Lot #: 160210-66, BUD: 08/08/16; Lot #: 160210-67, BUD: 08/08/16; Lot #: 160210-68, BUD: 08/08/16; Lot #: 160210-69, BUD: 08/08/16; Lot #: 160303-12, BUD: 08/30/16; Lot #: 160303-13, BUD: 08/30/16; Lot #: 160309-2, BUD: 09/05/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 16 of 88

EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY

D-1182-2016

Recall number: D-1182-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 24000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151202-45, BUD: 05/30/16; Lot #: 160105-38, BUD: 07/03/16; Lot #: 160114-20, BUD: 07/12/16; Lot #: 160217-28, BUD: 08/15/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 17 of 88

ESTRADIOLVAL 3MG/TEST CYP 35MG/ TEST PROP 35MG/ML W/PRES. (BENZYL ETOH 2%), 3ML Vials, MEDAUS PHARMACY

D-1183-2016

Recall number: D-1183-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 10 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151218-14, BUD: 06/15/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 18 of 88

FOLIC ACID 10MG/ML IN NACL (PF), 1ML Vials, MEDAUS PHARMACY

D-1184-2016

Recall number: D-1184-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 250 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151214-62, BUD: 06/11/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 19 of 88

FOLIC ACID 10MG/ML W/PRES. (METHYLPARABEN 0.05%, PROPYLPARABEN 0.025% IN NACL, 10ML Vials, MEDAUS PHARMACY

D-1185-2016

Recall number: D-1185-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 500 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160215-30, BUD: 08/13/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 20 of 88

GABA 50MG/ML (PF), 50ML Vials, MEDAUS PHARMACY

D-1186-2106

Recall number: D-1186-2106
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 110 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160315-14, BUD: 09/11/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 21 of 88

GERMANIUM SESO 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

D-1187-2016

Recall number: D-1187-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 49 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151229-21, BUD: 06/26/16; Lot #: 151229-25, BUD: 06/26/16; Lot #: 151229-31, BUD: 06/26/16; Lot #: 160126-14, BUD: 07/24/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 22 of 88

HYALURONIDASE 500U/ML(PF), 3ML Vials, MEDAUS PHARMACY

D-1188-2016

Recall number: D-1188-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 500 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151230-23, BUD: 06/27/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 23 of 88

HYDROGEN PEROXIDE 3% (PF), 5ML Vials, MEDAUS PHARMACY

D-1189-2016

Recall number: D-1189-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160112-35, BUD: 07/10/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 24 of 88

HYDROXY B12 5MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY

D-1190-2016

Recall number: D-1190-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 210 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160202-12, BUD: 07/11/16; Lot #: 160204-10, BUD: 07/11/16; Lot #: 160210-70, BUD: 07/11/16; Lot #: 160215-11, BUD: 07/11/16; Lot #: 160222-17, BUD: 07/11/16; Lot #: 160223-64, BUD: 07/11/16; Lot #: 160224-67, BUD: 07/11/16; Lot #: 160307-28, BUD: 07/11/16; Lot #: 160308-1, BUD: 07/11/16; Lot #: 160309-3, BUD: 07/11/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 25 of 88

HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY

D-1191-2016

Recall number: D-1191-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 800 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160119-8, BUD: 07/17/16; Lot #: 160204-30, BUD: 08/02/16. b) Lot #: 160119-8, BUD: 07/17/16; Lot #: 160204-30, BUD: 08/02/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 26 of 88

HYDROXY B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01%), 10ML Vials, MEDAUS PHARMACY

D-1192-2016

Recall number: D-1192-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 7000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151221-56, BUD: 06/18/16; Lot #: 160203-23, BUD: 08/01/16; Lot #: 160218-45, BUD: 08/16/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 27 of 88

HYDROXY B12 1000MCG/ML IN NACL 0.9% (PF), 1ML Vials, MEDAUS PHARMACY

D-1193-2016

Recall number: D-1193-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 300 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160104-64, BUD: 07/02/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 28 of 88

L-CARNITINE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

D-1194-2016

Recall number: D-1194-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1400 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151123-18, BUD: 05/21/16; Lot #: 151124-39, BUD: 05/22/16; Lot #: 160203-42, BUD: 08/01/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 29 of 88

L-CARNITINE 50MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

D-1195-2106

Recall number: D-1195-2106
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 2000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160303-62, BUD: 08/30/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 30 of 88

L-CARNITINE 250MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

D-1196-2016

Recall number: D-1196-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 2250 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151123-72, BUD: 05/21/16; Lot #: 151124-33, BUD: 05/22/16; Lot #: 151217-18, BUD: 06/14/16; Lot #: 151217-22, BUD: 06/14/16; Lot #: 151221-3, BUD: 06/18/16; Lot #: 160303-64, BUD: 08/30/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 31 of 88

L-CARNITINE 500MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

D-1197-2016

Recall number: D-1197-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 500 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160203-41, BUD: 08/01/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 32 of 88

L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDAUS PHARMACY

D-1198-2016

Recall number: D-1198-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 5000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160222-28, BUD: 05/22/16; Lot #: 160302-63, BUD: 05/31/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 33 of 88

L-PHENYLALANINE 15MG/ML (PF), 50ML Vials, MEDAUS PHARMACY

D-1199-2016

Recall number: D-1199-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 55 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160308-2, BUD: 09/04/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 34 of 88

LIDOCAINE 2% (PF) IN NACL, 10ML Vials, MEDAUS PHARMACY

D-1200-2016

Recall number: D-1200-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 147 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151203-48, BUD: 05/31/16; Lot #: 151204-9, BUD: 06/01/16; Lot #: 151218-20, BUD: 06/15/16; Lot #: 160125-23, BUD: 07/23/16; Lot #: 160125-24, BUD: 07/23/16; Lot #: 160125-25, BUD: 07/23/16; Lot #: 160127-6, BUD: 07/25/16; Lot #: 160302-76, BUD: 08/29/16; Lot #: 160302-77, BUD: 08/29/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 35 of 88

LIPO W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;D3-30MG; B5-5MG;B6-5MG;CYANO B12-1MG; METHIONINE 12.5MG; INOSITOL-25MG; CHOLINE CL-25 MG; LIDOCAINE 10MG/ML, In a) 5 ML Vials and b) 10ML Vials, MEDAUS PHARMACY

D-1201-2016

Recall number: D-1201-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 7000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160107-37, BUD: 07/5/16; Lot #: 160303-67, BUD: 07/31/16. b) Lot #: 160107-37, BUD: 07/5/16; Lot #: 160303-67, BUD: 07/31/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 36 of 88

LIPO #4 W/METHYL B12 500 MCG/ML/NO METHIONINE W/PRES (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;B3-30MG; B5-5MG;B6-5MG;METHYL B12 500 MCG; LIDOCAINE 10 MG; INOSITOL-25MG; CHOLINE CHL-25 MG/ML; 5ML Vials, MEDAUS PHARMACY

D-1202-2016

Recall number: D-1202-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160203-2, BUD: 07/31/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 37 of 88

LIPO-INJECTION W/LIDOCAINE (PF), ASCORBIC ACID 50MG; B1-50MG; B2-5-PO4-5MG; B3-50MG B5-5MG, B6-5MG, CYANO B-12-100MCG, METHIONINE 12.5 MG, INOSITOL 25 MG, CHOLINE CL-25 MG, LIDCAINE 10 MG/ML, 2ML Vials, MEDAUS PHARMACY

D-1203-2016

Recall number: D-1203-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151130-85, BUD: 05/26/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 38 of 88

LIPO B CYANO 1MG/ML W/PRES. (BENZYL ETOH 1%) METHIONINE 25MG, INOSITOL 50MG, CHOLINE CHL-50MG, CYANO B-12-100MCG, BENZYL ALCOHOL 1%/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

D-1204-2016

Recall number: D-1204-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 155 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 151203-50, BUD: 05/26/16; Lot #: 160128-34, BUD: 07/26/16; Lot #: 160229-51, BUD: 07/31/16. b) Lot #: 151204-10, BUD: 05/26/16; Lot #: 151204-19, BUD: 05/26/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 39 of 88

LIPO-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG, METHYL, B12-500MCG, CARNITINE 50 MG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE 30MG/ML, In a) 3ML Vials and b) 5ML Vials, MEDAUS PHARMACY

D-1205-2016

Recall number: D-1205-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 65 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160209-36, BUD: 07/31/16. b) Lot #: 151202-20, BUD: 05/26/16; Lot #: 151214-49, BUD: 05/26/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 40 of 88

LIPO-INJECTION W/METHYL B12 1 MG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-1MG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

D-1206-2016

Recall number: D-1206-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 2000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160208-41, BUD: 07/31/16. b) Lot #: 160208-41, BUD: 07/31/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 41 of 88

LIPO-INJECTION W/METHYL B12 500 MCG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

D-1207-2016

Recall number: D-1207-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 4000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 151210-40, BUD: 05/26/16; Lot #: 160229-60, BUD: 07/31/16. b) Lot #: 151210-40, BUD: 05/26/16; Lot #: 160229-60, BUD: 07/31/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 42 of 88

LIPO-INJECTION W/METHYL B12 500 MCG/CARNITINE/NO VIT C W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, CARNITINE 25MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

D-1208-2016

Recall number: D-1208-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 7000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 151228-58, BUD: 05/26/16; Lot #: 160203-6, BUD: 07/31/16. b) Lot #: 151228-58, BUD: 05/26/16; Lot #: 160203-6, BUD: 07/31/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 43 of 88

LIPO-INJECTION W/LIDOCAINE NO METHIONINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG,INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, 5ML Vials, MEDAUS PHARMACY

D-1209-2016

Recall number: D-1209-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 4000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151210-46, BUD: 06/07/16; Lot #: 160208-50, BUD: 07/31/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 44 of 88

LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

D-1210-2016

Recall number: D-1210-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 14000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160104-40, BUD: 05/26/16; Lot #: 160209-28, BUD: 07/31/16. b) Lot #: 160104-40, BUD: 05/26/16; Lot #: 160209-28, BUD: 07/31/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 45 of 88

MAGNESIUM CHL 200MG/ML (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

D-1211-216

Recall number: D-1211-216
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 5000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160203-19, BUD: 08/01/16; Lot #: 160222-60, BUD: 08/20/16. b) Lot #: 160203-19, BUD: 08/01/16; Lot #: 160222-60, BUD: 08/20/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 46 of 88

MANGANESE CHL 0.1MG/ML PF, 10ML Vials, MEDAUS PHARMACY

D-1212-2016

Recall number: D-1212-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151214-64, BUD: 5/31/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 47 of 88

MANGANESE SO4 0.1MG/ML (PF), In a) 2MLVials and b) 10ML Vials, MEDAUS PHARMACY

D-1213-2016

Recall number: D-1213-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 3000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160115-24, BUD: 07/13/16; Lot #: 160302-61, BUD: 08/29/16. b) Lot #: 160115-24, BUD: 07/13/16; Lot #: 160302-61, BUD: 08/29/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 48 of 88

METHYL B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01% IN NACL 0.9%, In a) 2ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY

D-1214-2016

Recall number: D-1214-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 8020 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 151218-30, BUD: 06/15/16; Lot #: 151221-70, BUD: 06/18/16. b) Lot #: 151221-78, BUD: 06/18/16; Lot #: 160217-40, BUD: 08/15/16. c) Lot #: 151221-78, BUD: 06/18/16; Lot #: 160217-40, BUD: 08/15/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 49 of 88

METHYL B12 1000MCG/ML/PYRIDOXINE 100MG W/PRES. (BENZALKONIUM 0.01%), In a) 1ML Vials and b) 10ML Vials, MEDAUS PHARMACY

D-1215-2016

Recall number: D-1215-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 20 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160222-85, BUD: 07/05/16. b) Lot #: 160222-85, BUD: 07/05/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 50 of 88

METHYL B12 10MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY

D-1216-2016

Recall number: D-1216-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160118-31, BUD: 07/16/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 51 of 88

METHYL B12 1000MCG/ML IN NACL 0.9% (PF), 2ML Vials, MEDAUS PHARMACY

D-1217-2016

Recall number: D-1217-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 2000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151218-28, BUD: 06/15/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 52 of 88

METHYL B12 5MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY

D-1218-2016

Recall number: D-1218-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 600 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151123-25, BUD: 05/21/16; Lot #: 160126-12, BUD: 07/24/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 53 of 88

METHYL B12 10MG/ML W/PRES (BENZALKONIUM 0.01%) IN NACL 0.9%, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY

D-1219-2016

Recall number: D-1219-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 331 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160201-11, BUD: 07/11/16; Lot #: 160215-13, BUD: 07/11/16; Lot #: 160309-4, BUD: 07/11/16. b) Lot #: 160315-1, BUD: 07/11/16; Lot #: 160201-11, BUD: 07/11/16; Lot #: 160210-71, BUD: 07/11/16; Lot #: 160309-4, BUD: 07/11/16. c) Lot #: 160125-17, BUD: 07/11/16; Lot #: 160210-35, BUD: 07/11/16; Lot #: 160222-20, BUD: 07/11/16; Lot #: 160204-46, BUD: 07/11/16; Lot #: 160307-25, BUD: 07/11/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 54 of 88

M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials, MEDAUS PHARMACY

D-1220-2016

Recall number: D-1220-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 187 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151130-48, BUD: 05/26/16; Lot #: 151215-7, BUD: 05/26/16; Lot #: 151216-12, BUD: 05/26/16; Lot #: 160106-27, BUD: 05/26/16; Lot #: 160113-38, BUD: 07/11/16; Lot #: 160223-33, BUD: 07/31/16; Lot #: 160307-36, BUD: 07/31/16; Lot #: 160307-52, BUD: 07/31/16; Lot #: 160308-5, BUD: 07/31/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 55 of 88

M.I.C./B-COMPLEX (PF) B1-50MG;B2-5-PO4-5MG;B3-50MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-5MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 2ML Vials, MEDAUS PHARMACY

D-1221-2016

Recall number: D-1221-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 3000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151220-5, BUD: 05/26/16; Lot #: 160127-25, BUD: 07/25/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 56 of 88

M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG, B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG, METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY

D-1222-2016

Recall number: D-1222-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 110 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160229-24, BUD: 07/25/16, Lot #: 160315-5, BUD: 07/25/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 57 of 88

M.I.C B-COMPLEX W/PRES. (BENZYL ETOH 2%) B1-50MG;B2-5-PO4-5MG;B3-50MG;B5-5MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-50MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 5ML Vials, MEDAUS PHARMACY

D-1223-2016

Recall number: D-1223-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1430 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160119-59; BUD: 05/26/16, Lot #: 151228-72; BUD: 05/26/16, Lot #: 160127-4; BUD: 05/26/16, Lot #: 160201-13; BUD: 05/26/16, Lot #: 160202-13; BUD: 05/26/16, Lot #: 160204-11; BUD: 05/26/16, Lot #: 160202-66; BUD: 06/11/16, Lot #: 160307-31; BUD: 06/11/16, Lot #: 160224-68; BUD: 06/11/16, Lot #: 160205-8; BUD: 06/11/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 58 of 88

M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

D-1224-2016

Recall number: D-1224-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 500 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160107-17, BUD: 07/05/16. b) Lot #: 160107-17, BUD: 07/05/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 59 of 88

M.I.C 25/50/50 W/METHYL B12 1MG/PYRIDOXAL 50MG/ML (PF), 1ML Vials, MEDAUS PHARMACY

D-1225-2016

Recall number: D-1225-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 2000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151223-63, BUD: 05/26/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 60 of 88

MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACY

D-1226-2016

Recall number: D-1226-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 21000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151130-64, BUD: 05/28/16, Lot #: 151228-22, BUD: 06/25/16, Lot #: 160210-29, BUD: 08/08/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 61 of 88

MOLYBDENUM 250MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY

D-1227-2016

Recall number: D-1227-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151209-24, BUD: 06/06/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 62 of 88

NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY

D-1228-2016

Recall number: D-1228-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 157,500 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 151217-47, BUD: 06/14/16; Lot #: 160112-51, BUD: 07/10/16; Lot #: 160127-43, BUD: 07/25/16; Lot #: 160218-8, BUD: 08/16/16; Lot #: 151211-26, BUD: 06/08/16. b) Lot #: 151211-26, BUD: 06/08/16; Lot #: 151217-47, BUD: 06/14/16; Lot #: 160112-51, BUD: 07/10/16; Lot #: 160127-43, BUD: 07/25/16; Lot #: 160218-8, BUD: 08/16/16. c) Lot #: 151211-26, BUD: 06/08/16; Lot #: 160112-51, BUD: 07/10/16; Lot #: 160127-43, BUD: 07/25/16; Lot #: 151217-47, BUD: 06/14/16; Lot #: 160218-8, BUD: 08/16/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 63 of 88

NA ASCORBATE 500MG/ML NON-CORN (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY

D-1229-2016

Recall number: D-1229-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 358000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 151201-30, BUD: 05/29/16; Lot #: 151209-26, BUD: 06/06/16; Lot #: 151216-63, BUD: 06/13/16; Lot #: 151231-11, BUD: 06/28/16; Lot #: 160105-4, BUD: 07/03/16; Lot #: 160125-41, BUD: 07/23/16; Lot #: 160211-20, BUD: 08/09/16. b) Lot #: 151201-30, BUD: 05/29/16; Lot #: 151209-26, BUD: 06/06/16; Lot #: 151216-63, BUD: 06/13/16; Lot #: 151231-11, BUD: 06/28/16; Lot #: 160105-4, BUD: 07/03/16; Lot #: 160125-41, BUD: 07/23/16; Lot #: 160511-20, BUD: 08/09/16. c) Lot #: 151201-30, BUD: 05/29/16; Lot #: 151209-26, BUD: 06/06/16; Lot #: 151216-63, BUD: 06/13/16; Lot #: 151231-11, BUD: 06/28/16; Lot #: 160105-4, BUD: 07/03/16; Lot #: 160125-41, BUD: 07/23/16; Lot #: 160511-20, BUD: 08/09/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 64 of 88

NANDROLONE DEC 200MG/ML W/PRES. (BENZYL ETOH 10%), In a) 2ML Vials, b) 4ML Vials, and c) 5ML Vials, MEDAUS PHARMACY

D-1230-2016

Recall number: D-1230-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 400 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160203-18, BUD: 08/01/16. b) Lot #: 160203-18, BUD: 08/01/16. c) Lot #: 160203-18, BUD: 08/01/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 65 of 88

NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY

D-1231-2016

Recall number: D-1231-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 104 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160204-29, BUD: 08/02/16. b) Lot #: 151123-73, BUD: 05/21/16; Lot #: 151124-42, BUD: 05/22/16; Lot #: 151201-20, BUD: 05/29/16; Lot #: 151215-10, BUD: 06/12/16; Lot #: 160229-46, BUD: 07/17/16; Lot #: 160202-33, BUD: 07/31/16. c) Lot #: 160315-9, BUD: 09/11/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 66 of 88

PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY

D-1232-2016

Recall number: D-1232-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1500 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160112-47, BUD: 07/10/16; Lot #: 160225-9, BUD: 08/23/16. b) Lot #: 160112-47, BUD: 07/10/16; Lot #: 160225-9, BUD: 08/23/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 67 of 88

PROLINE 100MG/ML (PF), 5ML Vials, MEDAUS PHARMACY

D-1233-2016

Recall number: D-1233-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 60 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160308-3, BUD: 09/04/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 68 of 88

PYRIDOXAL 50 MG/THIAMINE 50 MG/LIDOCAINE 1% NS (PF), 2ML Vials, MEDAUS PHARMACY

D-1234-2016

Recall number: D-1234-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160104-67, BUD: 07/02/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 69 of 88

PYRIDOXINE HCL 100MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY

D-1235-2016

Recall number: D-1235-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 2000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160126-20, BUD: 07/24/16. b) Lot #: 160126-20, BUD: 07/24/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 70 of 88

PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY

D-1236-2016

Recall number: D-1236-2016
Initiated: May 13, 2016
Classification: Class III
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 4000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151220-6, BUD: 06/17/16, Lot #: 160225-7, BUD: 08/23/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 71 of 88

RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY

D-1237-2016

Recall number: D-1237-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 35 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 151123-74, BUD: 05/21/16; Lot #: 160315-10, BUD: 09/11/16. b) Lot #: 160204-21, BUD: 08/02/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 72 of 88

SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY

D-1238-2016

Recall number: D-1238-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 884 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151130-35, BUD: 05/21/16; Lot #: 151202-28, BUD: 05/21/16; Lot #: 151223-68, BUD: 05/21/16; Lot #: 151216-20, BUD: 05/21/16; Lot #: 151123-77, BUD: 05/21/16; Lot #: 151204-22, BUD: 05/21/16; Lot #: 160111-30, BUD: 05/21/16; Lot #: 160112-27, BUD: 05/21/16; Lot #: 160120-8, BUD: 05/21/16; Lot #: 160118-12, BUD: 05/21/16; Lot #: 160119-20, BUD: 05/21/16; Lot #: 160202-37, BUD: 05/21/16; Lot #: 160208-61, BUD: 05/21/16; Lot #: 160208-62, BUD: 05/21/16; Lot #: 160216-37, BUD: 08/14/16; Lot #: 160216-38, BUD: 08/14/16; Lot #: 160216-35, BUD: 08/14/16; Lot #: 160216-40, BUD: 08/14/16; Lot #: 160223-27, BUD: 08/14/16; Lot #: 160229-43, BUD: 08/14/16; Lot #: 160303-22, BUD: 08/14/16; Lot #: 160309-17, BUD: 08/14/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 73 of 88

TAURINE 50 MG/ML (PF), In a) 1ML Vials, b) 10ML Vials, and c) 20ML Vials, MEDAUS PHARMACY

D-1239-2016

Recall number: D-1239-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 5500 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 151202-54, BUD: 05/30/16; Lot #: 160308-31, BUD: 09/04/16. b) Lot #: 151202-54, BUD: 05/30/16; Lot #: 160308-31, BUD: 09/04/16. c) Lot #: 151202-54, BUD: 05/30/16; Lot #: 160308-31, BUD: 09/04/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 74 of 88

TAURINE 50 MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY

D-1240-2016

Recall number: D-1240-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 10 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160315-4, BUD: 05/30/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 75 of 88

TESTOSTERONE CYP 100 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, and d) 5 ML Vials, MEDAUS PHARMACY

D-1241-2016

Recall number: D-1241-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 500 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160115-17, BUD: 07/13/16. b) Lot #: 160115-17, BUD: 07/13/16. c) Lot #: 160115-17, BUD: 07/13/16. d) Lot #: 160115-17, BUD: 07/13/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 76 of 88

TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML, and e) 5ML Vials, MEDAUS PHARMACY

D-1242-2016

Recall number: D-1242-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 8000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #151210-5, BUD: 06/07/16; Lot #160204-31, BUD: 08/02/16; Lot #160107-8, BUD: 07/05/16; Lot #160303-47, BUD: 08/30/16. b) Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160303-47, BUD: 08/30/16. c) Lot #151207-8, BUD: 06/04/16; Lot #160303-47, BUD: 08/30/16; Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160106-34, BUD: 07/04/16; Lot#160208-22, BUD: 08/06/16. d) Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160303-47, BUD: 08/30/16. e) Lot #151210-5, BUD: 06/07/16; Lot #160107-8, BUD: 07/05/16; Lot #160204-31, BUD: 08/02/16; Lot #160303-47, BUD: 08/30/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 77 of 88

TESTOSTERONE CYP 20 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials and b) 3ML Vials, MEDAUS PHARMACY

D-1243-2016

Recall number: D-1243-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 20 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160302-71, BUD: 08/29/16. b) Lot #: 151207-8, BUD: 06/04/16; Lot #: 160106-34, BUD: 07/04/16; Lot #: 160208-22, BUD: 08/16/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 78 of 88

TESTOSTERONE CYP 25 MG/ML W/PRES (BENZYL ETOH 2%), 5ML Vials, MEDAUS PHARMACY

D-1244-2016

Recall number: D-1244-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 13 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160115-20, BUD: 07/13/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 79 of 88

TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials, and e) 5ML Vials, MEDAUS PHARMACY

D-1245-2016

Recall number: D-1245-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 150 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160119-12, BUD: 07/17/16. b) Lot #: 160119-12, BUD: 07/17/16. c) Lot #: 160119-12, BUD: 07/17/16. d) Lot #: 160119-12, BUD: 07/17/16. e) Lot #: 160119-12, BUD: 07/17/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 80 of 88

THIAMINE 100 MG/ML, 2ML Vials, MEDAUS PHARMACY

D-1246-2016

Recall number: D-1246-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151210-17, BUD: 06/07/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 81 of 88

THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY

D-1247-2016

Recall number: D-1247-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 213 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160129-2, BUD: 06/07/16; Lot #: 160201-10, BUD: 06/07/16; Lot #: 160222-19, BUD: 06/07/16; Lot #: 160215-12, BUD: 06/07/16; Lot #: 160315-2, BUD: 06/07/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 82 of 88

TMG 100 MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

D-1248-2016

Recall number: D-1248-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 85 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160215-23, BUD: 08/13/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 83 of 88

TRYPTOPHAN 10MG/ML (PF), In a) 10ML Vials and b) 50ML Vials, MEDAUS PHARMACY

D-1249-2016

Recall number: D-1249-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 2000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

a) Lot #: 160125-14, BUD: 07/23/16; Lot #: 160315-12, BUD: 09/11/16. b) Lot #: 160125-14, BUD: 07/23/16; Lot #: 160315-12, BUD: 09/11/16.

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 84 of 88

ZINC CHLORIDE 10MG/ML IN NACL 0.29% (PF), 2ML Vials, MEDAUS PHARMACY

D-1250-2016

Recall number: D-1250-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 500 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160120-57, BUD: 07/18/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 85 of 88

ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY

D-1251-2016

Recall number: D-1251-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 2000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151203-53; BUD: 05/31/16; Lot #: 151217-38; BUD: 06/14/16; Lot #: 160208-36; BUD: 08/06/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 86 of 88

ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

D-1252-2016

Recall number: D-1252-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151217-12, BUD: 06/14/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 87 of 88

ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY

D-1253-2016

Recall number: D-1253-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 500 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 151217-38, BUD: 06/14/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

drug · product 88 of 88

HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY

D-1254-2016

Recall number: D-1254-2016
Initiated: May 13, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medaus, Inc.
Quantity: 1000 mL in Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot #: 160111-62, BUD: 07/09/16

Distribution pattern

U.S. Nationwide, Japan, and New Zealand.

Event summary

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Every recalled product in this event

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