EXTRA STRENGTH UN-ASPIRIN 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 EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 450…
- Recall number
- D-0491-2022
- 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
EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03
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