Phenobarbital Elixir recall
Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC…
Why was Phenobarbital Elixir recalled?
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 20FP1569 Exp. Date 08/2022; 21FP1674 Exp. Date 02/2023; 21FP1831 Exp. Date 08/2023
- Product
- Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC…
- Recalling firm
- Monarch PCM, LLC
- Quantity
- 15,730 bottles
- Distribution
- TN only
- Recall date
- May 25, 2022
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)