May 2011 FDA Recall Drug by Physicians Total Care, Inc.
D-301-2013 - Presence of Foreign Tablets/Capsules

This Class III drug recall was voluntarily initiated by Physicians Total Care, Inc. on May 23, 2011 for the product Drug. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed in FL and the recall is currently terminated.

Recall Number: D-301-2013

Reason for Recall
Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form.
Initiated
05-23-2011
Reported
05-08-2013
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65002
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
FL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-17-2013
Product Description About Product Description
Full technical description of the product.
Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK 74146; Mfg. By: Novartis Consumer Health I, Lincoln, NE 68581; NDC 54868-4710-0, Barcode 47101006IHD.

Batch or Lot Expiration Information

Lot# 6IHD, Exp 09/30/2013