D-0692-2018 Class II Terminated
FDA drug recall D-0692-2018 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 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., 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) C139C, C140C, exp 2/18, F044C, exp 8/18; b) D048C, D049C, D050C, D051C, C142C, C137C, C138C, C139C, C141C, exp 2/18; D052C, K207C, K208C, K209C, K210C, K211C, K212C, HM6122, HM6123, HM6124, HM6125, HM6126, K109C, K110C, K111C, HM6113, HM6114, HM6115, HM6116, HM6117, HM6118, F044C, H097C, H098C, H099C, H100C, H101C, K096C, K097C, K098C, K099C, K100C, K101C, K102C, exp 8/18; M105C, L017C, L018C, L019C, L020C, L021C, L022C, 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-0692-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026