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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89938

34 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 04, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Olympia Compounding Pharmacy dba Olympia Pharmacy

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

34 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 34

NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0083-00

D-0795-2022
Recall number
D-0795-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
16,329 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: E24026 BUD: 5/26/2022, E42112 BUD: 5/12/2022, E48024 BUD: 2/2/2022, F24014 BUD: 6/14/2022, G48028 BUD: 7/28/2022, H24016 BUD: 8/16/2022, H42010 BUD 8/10/2022, H48030 BUD: 8/11/2022, I47003 BUD: 8/11/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 2 of 34

Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. 73198-0113-10

D-0796-2022
Recall number
D-0796-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
45,935 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: D41012 BUD 4/12/2022, D41212 BUD: 4/12/2022, D47026 BUD: 4/26/2022, E41017 BUD: 5/17/2022, E41018 BUD: 5/18/2022, E47004 BUD: 5/4/2022, E47024 BUD: 5/24/2022, E47026 BUD: 5/26/2022, E48005 BUD: 5/5/2022, G47014 BUD: 7/14/2022, H48816 BUD: 8/16/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 3 of 34

Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00; b) 9 mg NDC 73198-0059-00, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.

D-0797-2022
Recall number
D-0797-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
18060 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: a) D41019 BUD: 4/19/2022; b) D41112 BUD: 4/12/2022, D47028 BUD: 4/28/2022, F24009 BUD 3/4/2022, F41001 BUD: 6/1/2022, G48006 BUD: 7/14/2022, G48008 BUD: 7/8/2022, G48012 BUD: 7/12/2022, G48014 BUD: 7/14/2022, G48019 BUD: 7/9/2022, I24009 BUD: 9/9/2022, I41107 BUD: 9/7/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 4 of 34

QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60 mcg/mL . Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0018-10.

D-0798-2022
Recall number
D-0798-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
1871 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: D41219 BUD: 4/19/2022, I24C13 BUD: 9/13/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 5 of 34

T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10; b) 5 ml Multi-Dose vial, NDC 73198-0005-05; c) 2.5 ml Multi-Dose vial, NDC 73198-0005-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835 .

D-0799-2022
Recall number
D-0799-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
6916 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: a) D41412 BUD: 4/22/2022, E41F10 BUD: 5/10/2022, E41G10 BUD: 5/10/2022, F24D21 BUD: 6/21/2022 ; b) D41512 BUD: 4/12/2022; c) F42B21 BUD: 6/21/2022, H42B03 BUD: 8/3/2022, H42C03 BUD: 8/3/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 6 of 34

Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0004-10

D-0800-2022
Recall number
D-0800-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
800 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: D41C19 BUD: 4/19/2022, I42C13 BUD: 9/13/2022, I42B13 BUD: 9/13/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 7 of 34

AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0040-10

D-0801-2022
Recall number
D-0801-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
1318 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: D41E20 BUD: 4/20/2022, D41F20 BUD: 4/20/2022, G41C13 BUD: 7/13/2022, G41B13 BUD: 7/13/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 8 of 34

AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine 0.2mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0039-10

D-0802-2022
Recall number
D-0802-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
310 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: F41C28 BUD: 6/28/2022, F41B28 BUD: 6/28/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 9 of 34

NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10

D-0803-2022
Recall number
D-0803-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
3509 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: I24C28 BUD: 9/28/2022, D41I19 BUD: 4/19/2022, F41321 BUD: 6/21/2022, I24128 BUD: 9/28/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 10 of 34

T-106, Papaverine 30 mg/mL . Phentolamine 1 mg/mL . Alprostadil 25 mcg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC: 73198-0013-10; b) 5 mL Multi-Dose vial, NDC 73198-0013-05; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.

D-0804-2022
Recall number
D-0804-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
4129 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: a) E24510 BUD: 5/10/2022, E24610 BUD: 5/10/2022; b) H42H03 BUD: 8/3/2022, E24810 BUD: 5/10/2022, H42203 BUD: 8/3/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 11 of 34

T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg/mL. Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0014-10; b) 5 mL Multi-Dose vial, NDC 73198-0014-05; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.

D-0805-2022
Recall number
D-0805-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
2437 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: a) E41B10 BUD: 5/10/2022; b) E41B08 BUD: 5/10/2022, I41C08 BUD: 9/8/2022, I41D08 BUD: 9/8/2022, E41C10 BUD: 5/10/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 12 of 34

SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0023-10.

D-0806-2022
Recall number
D-0806-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
1740 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: E41C18 BUD: 5/18/2022, E41D18 BUD: 5/18/2022, G42D20 BUD: 7/20/2022, G42B20 BUD: 7/20/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 13 of 34

SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0024-10.

D-0807-2022
Recall number
D-0807-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
1110 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: E48B18 BUD: 5/18/2022, E48D18 BUD; 5/18/2022, H24D31 BUD: 8/31/2022; E48C18 BUD: 5/18/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 14 of 34

SB-6, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 60 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0025-10.

D-0808-2022
Recall number
D-0808-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
336 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: E41H18 BUD: 5/18/2022, G41319 BUD: 7/19/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 15 of 34

ST-1, Papaverine 30 mg/mL . Phentolamine 1.5 mg/mL . Alprostadil 50 mcg/ml, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0011-10.

D-0809-2022
Recall number
D-0809-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
525 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: H24F03 BUD: 8/3/2022, H24E03 BUD: 8/3/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 16 of 34

ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0012-10.

D-0810-2022
Recall number
D-0810-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
2005 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: F41C21 BUD: 6/21/2022, G42013 BUD: 7/13/2022, H41C31 BUD: 8/31/2022, F41D21 BUD: 6/21/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 17 of 34

QM-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 150 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0019-10.

D-0811-2022
Recall number
D-0811-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
1679 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: E42B12 BUD: 5/12/2022, E42C12 BUD: 5/12/2022, E42D12 BUD: 5/12/2022, H24B23 BUD: 8/23/2022, H24C23 BUD: 8/23/2022, H24D23 BUD: 8/23/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 18 of 34

QM-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0020-10.

D-0812-2022
Recall number
D-0812-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
1647 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: E41027 BUD: 5/27/2022, I24E13 BUD: 9/13/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 19 of 34

RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0015-10; b) 2.5 mL Multi-Dose vial, NDC 73198-0015-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.

D-0813-2022
Recall number
D-0813-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
1849 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: a) E47B18 BUD: 5/18/2022; b) E47C18 BUD: 5/18/2022, H24G31 BUD: 8/31/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 20 of 34

RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0016-10.

D-0814-2022
Recall number
D-0814-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
2201 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: E42G11 BUD: 5/11/2022, H41003 BUD: 8/3/2022; H41B03 BUD: 8/3/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 21 of 34

BIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0027-10.

D-0815-2022
Recall number
D-0815-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
388 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lot: F24C10 BUD: 6/10/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 22 of 34

FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0006-10.

D-0816-2022
Recall number
D-0816-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
2887 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: F41414 BUD: 6/14/2022, F41C14 BUD: 6/14/2022, I24E28 BUD: 9/28/2022, I24F28 BUD: 9/28/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 23 of 34

PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0028-10.

D-0817-2022
Recall number
D-0817-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
821 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: I24028 BUD: 9/28/2022,F47C30 BUD: 6/30/2022, F47B30 BUD: 6/30/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 24 of 34

PGE-2, Alprostadil 80 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0029-10.

D-0818-2022
Recall number
D-0818-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
460 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lot: F48102 BUD: 6/2/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 25 of 34

PGE-3, Alprostadil 150 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0030-10.

D-0819-2022
Recall number
D-0819-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
410 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lot: G24C19 BUD: 7/19/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 26 of 34

T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0022-10.

D-0820-2022
Recall number
D-0820-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
1097 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: G24F01 BUD: 7/1/2022, G41316 BUD: 7/16/2022, H24B03 BUD: 8/3/2022, H24C03 BUD: 8/3/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 27 of 34

Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0002-10.

D-0821-2022
Recall number
D-0821-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
257 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: G48C20 BUD: 7/20/2022, G48B20 BUD: 7/22/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 28 of 34

Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0021-05.

D-0822-2022
Recall number
D-0822-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
4521 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lot: H47030 BUD: 8/30/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 29 of 34

Testosterone Cypionate 200 mg/mL (in Grapeseed Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0054-10; b) 5 mL Multi-Dose vial, NDC 73198-0054-05, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.

D-0823-2022
Recall number
D-0823-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
7161 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: a) D48027 BUD: 4/27/2022,E47017 BUD: 5/17/2022, F42007 BUD: 6/7/2022, F42107 BUD: 6/7/2022, F42207 BUD: 6/7/2022, F48009 BUD: 6/9/2022, F48109 BUD: 6/9/2022, H47003 BUD: 8/3/2022; b) F24024 BUD: 6/24/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 30 of 34

Testosterone Cypionate 200 mg/mL, (in Sesame Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0055-10; b) 5 mL Multi-Dose vial, NDC 73198-0055-05, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.

D-0824-2022
Recall number
D-0824-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
3962 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: a) E48019 BUD: 5/19/2022, F42109 BUD: 6/9/2022, F42C09 BUD: 6/9/2022, G47012 BUD: 7/12/2022, G47112 BUD: 7/12/2022; b) F42B09 BUD: 6/9/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 31 of 34

Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0058-10.

D-0825-2022
Recall number
D-0825-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
1276 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: E48020 BUD: 5/20/2022 and G47006 BUD: 7/6/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 32 of 34

Hydroxocobalamin B12, 1 mg/mL, 30 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0080-30.

D-0826-2022
Recall number
D-0826-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
6431 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: D48026 BUD: 4/26/2022, E48025 BUD: 5/25/2022, G48B21 BUD: 7/21/2022, G48C21 BUD: 7/21/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 33 of 34

Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0082-00.

D-0827-2022
Recall number
D-0827-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
1770 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Code information

Lots: F24018 BUD: 6/18/2022 and G47021 BUD: 7/21/2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 34 of 34

NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0083-00

D-0828-2022
Recall number
D-0828-2022
Initiated
April 04, 2022
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Reconstitution time

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Reconstitution time

Code information

Lot: F41116 BUD: 6/16/2022,

Distribution pattern

Distributed Nationwide in the USA