D-0686-2018 Class II Terminated
FDA drug recall D-0686-2018 was initiated by Time-Cap Laboratories, Inc. on January 11, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. The recall status is terminated (terminated January 20, 2021). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- May 2, 2018
- Initiation Date
- January 11, 2018
- Termination Date
- January 20, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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
Reason for Recall
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Distribution Pattern
Nationwide.
Code Information
a) D167C, exp 2/18, E135C, exp 3/18; b) D172C, exp 2/18; c) D167C, exp 2/18, E135C, exp 3/18