Recalls / Class III
Class IIID-0878-2022
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
- Affected lot / code info
- Lot #: 20FP1569 Exp. Date 08/2022; 21FP1674 Exp. Date 02/2023; 21FP1831 Exp. Date 08/2023
Why it was recalled
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Recalling firm
- Firm
- Monarch PCM, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7333 Jack Newell Blvd N Ste 100, N/A, Fort Worth, Texas 76118-7151
Distribution
- Quantity
- 15,730 bottles
- Distribution pattern
- TN only
Timeline
- Recall initiated
- 2022-04-14
- FDA classified
- 2022-05-17
- Posted by FDA
- 2022-05-25
- Terminated
- 2023-06-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0878-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.