Drug 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
D-0878-2022
Product summary
- Firm
- Monarch PCM, LLC
- Event
- Event 90062
- Status
- Terminated
- Classification
- Class III
- Quantity
- 15,730 bottles
- Official record key
drug-enforcement:D-0878-2022
Official wording
Reason: Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Code information: Lot #: 20FP1569 Exp. Date 08/2022; 21FP1674 Exp. Date 02/2023; 21FP1831 Exp. Date 08/2023
Distribution pattern: TN only
Derived failure modes
-
Unknown
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content