FDA Media Alert Detail

Drug Recall

FDA Drug Recall: Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bot...

  • U.S. Food and Drug Administration
  • June 20, 2012
  • ID: D-1379-2012

Drug Enforcement Report Details

Recall NumberD-1379-2012
Recalling FirmPhysicians Total Care, Inc.
ClassificationClass II
Voluntary / MandatedVoluntary: Firm initiated
Distribution PatternNC and KY
StatusTerminated
Product Description

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 for Recall

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


Content syndicated from the U.S. Food and Drug Administration (FDA) drug enforcement reports database.