Monarch PCM, LLC: Drug Recall
Recall #D-0878-2022 · 04/14/2022
Class III: Low Risk
Recall Details
- Recall Number
- D-0878-2022
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Monarch PCM, LLC
- Status
- Terminated
- Date Initiated
- 04/14/2022
- Location
- Fort Worth, TX, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,730 bottles
Reason for Recall
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Product Description
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
Distribution Pattern
TN only
Other Recalls by Monarch PCM, LLC
- Class II: Risk 09/23/2021
- Class III: Low Risk 09/01/2021
- Class III: Low Risk 09/01/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.