Drug 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.
D-1379-2012
Product summary
- Event
- Event 62135
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 4 bottles; b) 2 bottles
- Official record key
drug-enforcement:D-1379-2012
Official wording
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.
Code information: Lot #: a) 5NON, Exp 04/13; 5YUN, Exp 09/13; b) 5KBJ, Exp 02/13; 5LVX, Exp 04/13
Distribution pattern: NC and KY
Derived failure modes
-
Unknown
Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.