Ibuprofen Tablets recalled over manufacturing violations
- Recall date
- January 11, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Time-Cap Laboratories, Inc. recalls Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 5…
- Recall number
- D-0686-2018
- FDA classification
- Class II
- Brand / firm
- Time-Cap Laboratories, Inc.
- Sold / distributed
- Nationwide.
Why it was recalled
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256
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