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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77770

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

Open FDA event record

Event summary

Timeline bucket
July 14, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SCA Pharmaceuticals

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

30 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 30

BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0060-40

D-1005-2017
Recall number
D-1005-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170429@33 BUD: 7/28/2017, 20170503@23 BUD: 8/1/2017

Distribution pattern

Nationwide

drug · product 2 of 30

BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivacaine 312.5 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0062-40

D-1006-2017
Recall number
D-1006-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lot: 20170502@32 BUD: 7/31/2017

Distribution pattern

Nationwide

drug · product 3 of 30

BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose Bupivacaine 500 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0066-40

D-1007-2017
Recall number
D-1007-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lot: 20170501@69 BUD: 7/30/2017

Distribution pattern

Nationwide

drug · product 4 of 30

fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag (Total fentaNYL Dose 1250 mcg/ 250 mL), Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0201-40

D-1008-2017
Recall number
D-1008-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170428@57 BUD: 7/27/2017; 20170428@58 BUD: 7/27/2017; 20170511@24 BUD: 8/9/2017

Distribution pattern

Nationwide

drug · product 5 of 30

fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40

D-1009-2017
Recall number
D-1009-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170502@18 BUD: 7/31/2017; 20170502@39 BUD: 7/31/2017; 20170502@62 BUD: 7/31/2017; 20170503@22 BUD: 8/1/2017; 20170503@4 BUD: 8/1/2017; 20170503@54 BUD: 8/1/2017; 20170504@10 BUD: 8/2/2017; 20170505@15 BUD: 8/3/2017; 20170506@23 BUD: 8/4/2017

Distribution pattern

Nationwide

drug · product 6 of 30

fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0225-24

D-1010-2017
Recall number
D-1010-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lot: 20170510@40 BUD: 8/8/2017

Distribution pattern

Nationwide

drug · product 7 of 30

fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0226-40

D-1011-2017
Recall number
D-1011-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170429@29 BUD: 7/28/2017; 20170512@24 BUD: 8/10/2017

Distribution pattern

Nationwide

drug · product 8 of 30

fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-05

D-1012-2017
Recall number
D-1012-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lot: 20170512@19 BUD: 8/10/2017

Distribution pattern

Nationwide

drug · product 9 of 30

fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-40

D-1013-2017
Recall number
D-1013-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170509@20 BUD: 8/7/2017; 20170509@21 BUD: 8/7/2017; 20170509@46 BUD: 8/7/2017; 20170511@33 BUD: 8/9/2017

Distribution pattern

Nationwide

drug · product 10 of 30

fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0230-40

D-1014-2017
Recall number
D-1014-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170502@47 BUD: 7/31/2017; 20170502@56 BUD: 7/31/2017; 20170505@26 BUD: 8/3/2017; 20170506@25 BUD: 8/4/2017

Distribution pattern

Nationwide

drug · product 11 of 30

fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0254-40

D-1015-2017
Recall number
D-1015-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170503@75 BUD: 8/1/2017; 20170511@21 BUD: 8/9/2017

Distribution pattern

Nationwide

drug · product 12 of 30

fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0290-40

D-1016-2017
Recall number
D-1016-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lot: 20170506@27 BUD: 8/4/2017

Distribution pattern

Nationwide

drug · product 13 of 30

Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05

D-1017-2017
Recall number
D-1017-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lot: 20170508@75 BUD: 8/6/2017

Distribution pattern

Nationwide

drug · product 14 of 30

ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0600-11

D-1018-2017
Recall number
D-1018-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170503@28 BUD: 7/17/2017; 20170508@60 BUD: 7/22/2017

Distribution pattern

Nationwide

drug · product 15 of 30

EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0613-40

D-1019-2017
Recall number
D-1019-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170508@51 BUD: 9/10/2017; 20170503@17 BUD: 9/5/2017

Distribution pattern

Nationwide

drug · product 16 of 30

NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0771-40

D-1020-2017
Recall number
D-1020-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170502@36 BUD: 7/31/2017; 20170512@1 BUD: 8/10/2017; 20170504@13 BUD: 8/2/2017; 20170504@18 BUD: 8/2/2017

Distribution pattern

Nationwide

drug · product 17 of 30

NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40

D-1021-2017
Recall number
D-1021-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170502@31 BUD: 7/16/2017; 20170508@34 BUD: 7/22/2017; 20170508@70 BUD: 7/22/2017; 20170512@15 BUD: 7/26/2017

Distribution pattern

Nationwide

drug · product 18 of 30

NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0775-40

D-1022-2017
Recall number
D-1022-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170512@8 BUD: 8/10/2017; 20170506@18 BUD: 8/4/2017

Distribution pattern

Nationwide

drug · product 19 of 30

PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40

D-1023-2017
Recall number
D-1023-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170502@53 BUD: 7/31/2017; 20170505@16 BUD: 8/3/2017

Distribution pattern

Nationwide

drug · product 20 of 30

PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0810-40

D-1024-2017
Recall number
D-1024-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170512@20 BUD: 8/10/2017; 20170504@61 BUD: 8/2/2017

Distribution pattern

Nationwide

drug · product 21 of 30

PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0811-40

D-1025-2017
Recall number
D-1025-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170503@26 BUD: 8/1/2017; 20170510@48 BUD: 8/8/2017

Distribution pattern

Nationwide

drug · product 22 of 30

PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0811-59

D-1026-2017
Recall number
D-1026-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170503@29 BUD: 8/1/2017; 20170512@22 BUD: 8/10/2017; 20170509@64 BUD: 8/7/2017

Distribution pattern

Nationwide

drug · product 23 of 30

PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40

D-1027-2017
Recall number
D-1027-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170429@28 BUD: 7/28/2017; BUD: 20170509@65 BUD: 8/7/2017

Distribution pattern

Nationwide

drug · product 24 of 30

PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0813-40

D-1028-2017
Recall number
D-1028-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lot: 20170503@16 BUD: 8/1/2017

Distribution pattern

Nationwide

drug · product 25 of 30

PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0815-40

D-1029-2017
Recall number
D-1029-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lot: 20170511@51 BUD: 8/9/2017

Distribution pattern

Nationwide

drug · product 26 of 30

PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40

D-1030-2017
Recall number
D-1030-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lot: 20170503@19 BUD: 8/1/2017

Distribution pattern

Nationwide

drug · product 27 of 30

PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0820-40

D-1031-2017
Recall number
D-1031-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170512@6 BUD: 8/10/2017; 20170511@56 BUD: 8/9/2017

Distribution pattern

Nationwide

drug · product 28 of 30

Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0832-40

D-1032-2017
Recall number
D-1032-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170501@66 BUD: 7/15/2017

Distribution pattern

Nationwide

drug · product 29 of 30

Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40

D-1033-2017
Recall number
D-1033-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170509@10 BUD: 7/23/2017

Distribution pattern

Nationwide

drug · product 30 of 30

fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40

D-1034-2017
Recall number
D-1034-2017
Initiated
July 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Code information

Lots: 20170509@17 BUD: 8/7/2017

Distribution pattern

Nationwide