Class III
Terminated
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
- Company
- Monarch Pcm, Llc
- Recall Initiated
- April 14, 2022
- Posted
- May 25, 2022
- Recall Number
- D-0878-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 15,730 bottles
- Firm Location
- Fort Worth, TX, United States
Reason for Recall
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Distribution
TN only
Lot / Code Info
Lot #: 20FP1569 Exp. Date 08/2022; 21FP1674 Exp. Date 02/2023; 21FP1831 Exp. Date 08/2023
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