D-0687-2018 Class II Terminated
FDA drug recall D-0687-2018 was initiated by Time-Cap Laboratories, Inc. on Jan 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 Jan 20, 2021).
Recall details
- Product Type
- Drugs
- Report Date
- May 2, 2018
- Initiation Date
- Jan 11, 2018
- Termination Date
- Jan 20, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
Product description
Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
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) M104C, exp 9/18, L016C, H092C, and H093C, exp 9/18 b) C128C, C129C, C130C, C132C, exp 3/18, HK6011, exp 7/18, L016C and H092C, exp 9/18,
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0687-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026