FDA Drug recall D-1379-2012
Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1)
- FDA Drug
- Class II
- terminated
- Published 2012-06-20
On 2012-06-20 the FDA classified a Class II recall of Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1) by Physicians Total Care, citing tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1379-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-09-19 |
| Published | 2012-06-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Physicians Total Care |
| Distribution | KY, NC |
Product
Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1); b) 60-count tablets per bottle (NDC 54868-4165-0); Rx only, Mfg. By: G.D. searle LLC Div Pfizer, New York, NY 10017; Repacked & distributed by: Physicians total Care, Inc., Tulsa, OK 74146.
Reason
Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.
Identifiers
| code_info | Lot #: a) 5NON, Exp 04/13; 5YUN, Exp 09/13; b) 5KBJ, Exp 02/13; 5LVX, Exp 04/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1379-2012%22
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