Phenobarbital Elixir recalled for exceeding alcohol content specification
Monarch PCM, LLC is recalling Phenobarbital Elixir USP 20 mg/5 mL because the product exceeds the USP specification for alcohol content. Approximately 15,730 bottles distributed in Tennessee are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. The hazard is a specification violation for alcohol content in a pharmaceutical formulation, placing it at Moderate severity per FDA classification guidelines for Class III recalls.
Plain-English summary
Monarch PCM, LLC is recalling Phenobarbital Elixir, USP 20 mg/5 mL, 1-pint (473 mL) bottles because the product exceeds the United States Pharmacopeia (USP) specification for alcohol content. The product does not meet USP monograph specifications.
Approximately 15,730 bottles are affected by this recall. The affected lots are: #20FP1569 (expiring 08/2022), #21FP1674 (expiring 02/2023), and #21FP1831 (expiring 08/2023). The product was distributed in Tennessee.
Consumers and healthcare providers who have this recalled product should contact Monarch PCM, LLC. Patients should consult with their healthcare provider regarding what to do with the recalled medication.
The recalled product
- 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
- Manufacturer
- Monarch PCM, LLC
- Hazard
- alcohol-excess
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 20FP1569 Exp. Date 08/2022
- 21FP1674 Exp. Date 02/2023
- 21FP1831 Exp. Date 08/2023
Distribution
Distributed in 1 state:
- TN
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