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
Reported: November 30, 2022 Initiated: November 14, 2022 #D-0069-2023
Product Description
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
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.
Details
- Recalling Firm
- Acella Pharmaceuticals, LLC
- Units Affected
- 574 cartons
- Distribution
- Nationwide in the USA.
- Location
- Alpharetta, GA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Acella Pharmaceuticals, LLC. Units affected: 574 cartons.
Why was this product recalled? ▼
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 30, 2022. Severity: Low. Recall number: D-0069-2023.
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