Monarch PCM, LLC recalls Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals,…
- Recall date
- April 14, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0878-2022
- FDA classification
- Class III
- Brand / firm
- Monarch PCM, LLC
- Sold / distributed
- TN only
Why it was recalled
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Class III means the product violates regulations but is not likely to cause harm.
What 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
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