September 2011 FDA Recall Drug by Physicians Total Care, Inc.
D-1379-2012 - Tablet Separation

This Class II drug recall was voluntarily initiated by Physicians Total Care, Inc. on September 19, 2011 for the product Drug. The FDA reported the reason for recall as tablet separation. The product was distributed in NC and KY and the recall is currently terminated.

Recall Number: D-1379-2012

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.
Initiated
09-19-2011
Reported
06-20-2012
Quantity
a) 4 bottles; b) 2 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62135
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Physicians Total Care, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
FAX
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC and KY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-22-2013
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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