September 2014 FDA Recall Drug by Physicians Total Care, Inc.
D-0237-2015 - CGMP deviations

This Class II drug recall was voluntarily initiated by Physicians Total Care, Inc. on September 22, 2014 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distributed in Georgia and Missouri. and the recall is currently terminated.

Recall Number: D-0237-2015

Reason for Recall
CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Initiated
09-22-2014
Reported
11-12-2014
Quantity
340 capsules (17 bottles containing 20 capsules each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69597
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in Georgia and Missouri.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-16-2015
Product Description About Product Description
Full technical description of the product.
CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Pharmaceuticals, Fort Worth, TX 76155 and repackaged by Physicians Total Care, Inc., Tulsa, OK 74146-6233

Batch or Lot Expiration Information

Lot# Lot Code: 79MI (Exp. Date 01/31/2015), 79SF (Exp. Date 01/31/2015), 7AH5 (Exp. Date 06/30/2015)