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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77314

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

Open FDA event record

Event summary

Timeline bucket
May 18, 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

10 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 10

morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32.

D-0870-2017
Recall number
D-0870-2017
Initiated
May 18, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
80 bags

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 bags leaking at seam.

Code information

LOT # 20170508@57, Use By: 08/06/17

Distribution pattern

Nationwide in the USA

drug · product 2 of 10

morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-55

D-0871-2017
Recall number
D-0871-2017
Initiated
May 18, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
56 bags

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 bags leaking at seam.

Code information

LOT # 20170508@48, Use By: 08/06/17; 20170505@19, Use By: 08/03/17

Distribution pattern

Nationwide in the USA

drug · product 3 of 10

fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32

D-0872-2017
Recall number
D-0872-2017
Initiated
May 18, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
118 bags

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 bags leaking at seam.

Code information

LOT # 20170505@14, Use By: 08/03/17; 20170510@2, Use By: 08/08/17

Distribution pattern

Nationwide in the USA

drug · product 4 of 10

fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32

D-0873-2017
Recall number
D-0873-2017
Initiated
May 18, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
370 bags

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 bags leaking at seam.

Code information

LOT # 20170506@14, Use By: 08/04/17

Distribution pattern

Nationwide in the USA

drug · product 5 of 10

fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32

D-0874-2017
Recall number
D-0874-2017
Initiated
May 18, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
100 bags

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 bags leaking at seam.

Code information

LOT # 20170508@59, Use By: 08/06/17

Distribution pattern

Nationwide in the USA

drug · product 6 of 10

HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55

D-0875-2017
Recall number
D-0875-2017
Initiated
May 18, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
87 bags

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 bags leaking at seam.

Code information

LOT # 20170505@23, 20170505@28, Use By: 08/03/17

Distribution pattern

Nationwide in the USA

drug · product 7 of 10

ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0522-32

D-0876-2017
Recall number
D-0876-2017
Initiated
May 18, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
240 bags

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 bags leaking at seam.

Code information

LOT # 20170510@12, Use By: 06-24-17

Distribution pattern

Nationwide in the USA

drug · product 8 of 10

ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32

D-0877-2017
Recall number
D-0877-2017
Initiated
May 18, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
70 bags

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 bags leaking at seam.

Code information

LOT # 20170508@15, Use By: 06/22/17

Distribution pattern

Nationwide in the USA

drug · product 9 of 10

MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32

D-0878-2017
Recall number
D-0878-2017
Initiated
May 18, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
40 bags

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 bags leaking at seam.

Code information

LOT # 20170509@29, Use By: 08/07/17

Distribution pattern

Nationwide in the USA

drug · product 10 of 10

PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32

D-0879-2017
Recall number
D-0879-2017
Initiated
May 18, 2017
Classification
Class II
Status
Terminated
Recalling firm
SCA Pharmaceuticals
Quantity
30 bags

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 bags leaking at seam.

Code information

LOT # 20170511@17, Use By: 08/09/17

Distribution pattern

Nationwide in the USA