Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16

FDA recall notice · announced May 25, 2022 · Monarch Pcm

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16

Reason for recall

Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content

Notes

Distribution: TN only
Lot/code information: Lot #: 20FP1569 Exp. Date 08/2022; 21FP1674 Exp. Date 02/2023; 21FP1831 Exp. Date 08/2023
Quantity: 15,730 bottles
Status: Terminated
Products in this recall event:
- Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16 (D-0878-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.