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
Reported: May 25, 2022 Initiated: April 14, 2022 #D-0878-2022
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
Reason for Recall
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Details
- Recalling Firm
- Monarch PCM, LLC
- Units Affected
- 15,730 bottles
- Distribution
- TN only
- Location
- Fort Worth, TX
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Monarch PCM, LLC. Units affected: 15,730 bottles.
Why was this product recalled? ▼
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 25, 2022. Severity: Low. Recall number: D-0878-2022.
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