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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91149

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

Open FDA event record

Event summary

Timeline bucket
November 14, 2022
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Acella Pharmaceuticals, LLC

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

2 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 2

Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

D-0069-2023
Recall number
D-0069-2023
Initiated
November 14, 2022
Classification
Class III
Status
Terminated
Quantity
574 cartons

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label was missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Code information

Lot: E025A001 Exp. 07/2023

Distribution pattern

Nationwide in the USA.

drug · product 2 of 2

Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

D-0070-2023
Recall number
D-0070-2023
Initiated
November 14, 2022
Classification
Class III
Status
Terminated
Quantity
637 cartons

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label was missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Code information

Lot: E026A001 Exp. 06/2023

Distribution pattern

Nationwide in the USA.