FDAClass IIJune 20, 2012

Arthrotec 75 recall

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.

Why was Arthrotec 75 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.
Recalling firm
Physicians Total Care, Inc.
Quantity
a) 4 bottles; b) 2 bottles
Distribution
NC and KY
Recall date
June 20, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls