Reported May 25, 2022 · Terminated
Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals,…
Monarch PCM, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Monarch PCM, LLC · 7333 Jack Newell Blvd N Ste 100 · Fort Worth, TX · 76118-7151
Is this the product you have?
- Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only
- Manufactured forWestminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16
- Lot codes and dates
Lot #: 20FP1569 Exp. Date 08/202221FP1674 Exp. Date 02/202321FP1831 Exp. Date 08/2023
- Amount recalled
- 15,730 bottles
Where it was sold
Why it was recalled
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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