FDA Drug recall D-0685-2018
Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d)…
- FDA Drug
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d)… 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-0685-2018 |
| 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 Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d) 1000 tablets (NDC 49489-601-10), e) Bulk (49483-601-00) bottles, Brown, Manufactured for: Time Cap Labs, Inc., Farmingdale, NY 11735, 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 | 49483-114-50 |
|---|---|
| ndc | 49483-114-10 |
| ndc | 49483-114-17 |
| ndc | 49483-114-73 |
| ndc | 49483-601-00 |
| ndc | 49483-601-05 |
| ndc | 49483-601-01 |
| ndc | 49483-601-50 |
| ndc | 49483-601-10 |
| ndc | 49483-600-05 |
| ndc | 49483-600-01 |
| ndc | 49483-600-50 |
| ndc | 49489-601-10 |
| code_info | a) D167C, exp 2/18; b) D172C, exp 2/18, H057C, exp 6/18; c) D164C, exp 2/18, E135C, exp 3/18; d) D172C, exp…a) D167C, exp 2/18; b) D172C, exp 2/18, H057C, exp 6/18; c) D164C, exp 2/18, E135C, exp 3/18; d) D172C, exp 2/18, E135C, exp 3/18, F004C, exp 5/18; e) D175C, D176C, D177C, D178C, D179C, D180C, D162C, D163C, D164C, D165C, D166C, D168C, D169C, D170C, D171C, D173C, E104C, E105C, D191C, D192C, D193C, D194C, D195C, D196C, D197C, D198C, D199C, D200C, D201C, E106C, exp 2/18; L111C, F005C, F006C, F007C, F008C, H053C, H054C, H055C, H056C, exp 5/18; L112C, L113C, L114C, L115C, L116C, L117C, L118C, L119C, J008C, J009C, H057C, H058C, exp 6/18; L120C, L121C, L122C, L123C, L124C, exp 8/18 |
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-0685-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.