FDA Drug recall D-0695-2018
Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC 53493-292-14) bo…
- FDA Drug
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC 53493-292-14) bo… by Time Cap Laboratories, citing CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0695-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-11 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Time Cap Laboratories |
| Distribution | US |
Product
Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC 53493-292-14) bottles, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Identifiers
| ndc | 53943-292-15 |
|---|---|
| ndc | 53943-292-12 |
| ndc | 53943-292-14 |
| ndc | 53493-292-12 |
| ndc | 53493-292-14 |
| code_info | a) F066C b) F066C c) F066C |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0695-2018%22
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