FDA-Drug2018-05-02Class II

Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256

Time-Cap Laboratories, Inc.
Hazard

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Sold states
Nationwide.
Affected count
N/A
Manufactured in
7 Michael Ave, N/A, Farmingdale, NY, United States
Products
Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0691-2018

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