Food, drugs, devices › Acella Pharmaceuticals, LLC
Drug recall: 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,
FDA enforcement event 91149 is a drug recall by Acella Pharmaceuticals, LLC of Alpharetta, GA, initiated 14 Nov 2022 and classified Class III, with 2 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 18% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 21 Aug 2024. Initiation: voluntary: firm initiated. Acella Pharmaceuticals, LLC has 8 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Acella Pharmaceuticals, LLC, Alpharetta, GA.
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."
Distribution
"Nationwide in the USA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0069-2023 | 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 | 574 cartons | Class III | Terminated | 30 Nov 2022 |
| D-0070-2023 | 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 | 637 cartons | Class III | Terminated | 30 Nov 2022 |
Context
Other enforcement events for Acella Pharmaceuticals, LLC
All 8 events for Acella Pharmaceuticals, LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Aug 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.