Recalls / Class II

Class IID-1379-2012

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.

Affected lot / code info

Lot #: a) 5NON, Exp 04/13; 5YUN, Exp 09/13; b) 5KBJ, Exp 02/13; 5LVX, Exp 04/13

Why it was recalled

Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.

Recalling firm

Firm

Physicians Total Care, Inc.

Notification channel

FAX

Type

Voluntary: Firm initiated

Address

12515 E 55th St Ste 100, Tulsa, Oklahoma 74146-6234

Distribution

Quantity

a) 4 bottles; b) 2 bottles

Distribution pattern

NC and KY

Timeline

Recall initiated

2011-09-19

FDA classified

2012-06-14

Posted by FDA

2012-06-20

Terminated

2013-02-22

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1379-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.