FDA Drug recall D-0689-2018
Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time Cap…
- FDA Drug
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time Cap… 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-0689-2018 |
| 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 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time Caps Labs, Farmingdale, NY, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate 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 | 49483-602-01 |
|---|---|
| ndc | 49483-602-50 |
| ndc | 49483-603-03 |
| ndc | 49483-603-50 |
| ndc | 49483-603-05 |
| ndc | 49483-603-01 |
| ndc | 49483-604-01 |
| ndc | 49483-604-50 |
| ndc | 49483-604-05 |
| ndc | 49483-604-03 |
| code_info | a) C135C, D044C, D045C, D038C, exp 3/18, F069C, exp 4/18, H095C, exp 9/18 b) C134C, C136C, D039C, D040C, D041C, D04…a) C135C, D044C, D045C, D038C, exp 3/18, F069C, exp 4/18, H095C, exp 9/18 b) C134C, C136C, D039C, D040C, D041C, D042C, D043C, exp 3/18, F043C F067C, F068C, D046C, D047C, exp 4/18, H094C, exp 7/18 H096C, L026C, and H095C, exp 9/18 |
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-0689-2018%22
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