FDA Drug recall D-0239-2018
Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by…
- FDA Drug
- Class II
- terminated
- Published 2018-01-31
On 2018-01-31 the FDA classified a Class II recall of Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by… by Marksans Pharma, 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-0239-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-09 |
| Published | 2018-01-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Marksans Pharma |
| Distribution | US |
Product
Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-122-28.
Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Identifiers
| code_info | Lot #: HN6004, HN6005, HN6006, HN6007, HN6008, HN6009, HN6010, HN6011, HN6012, HN6013, HN6014, Exp 03/18; HN6015, HN601…Lot #: HN6004, HN6005, HN6006, HN6007, HN6008, HN6009, HN6010, HN6011, HN6012, HN6013, HN6014, Exp 03/18; HN6015, HN6016, HN6017, HN6018, HN6019, HN6020, HN6021, HN6022, HN6023, Exp 04/18; HN6024, Exp 07/18; HN6025, HN6026, HN6027, Exp 09/18 |
|---|
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-0239-2018%22
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