PAINAID PMF Premenstrual Formula 2 caplet packets recalled over manufacturing violations
- Recall date
- January 24, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Ultra Seal Corporation recalls PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distribut…
- Recall number
- D-0494-2022
- FDA classification
- Class II
- Brand / firm
- Ultra Seal Corporation
- Sold / distributed
- Nationwide within the United States
Why it was recalled
cGMP deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0046-03
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