June 2013 FDA Recall Drug by Physicians Total Care, Inc.
D-826-2013 - Presence of Foriegn Substance

This Class II drug recall was voluntarily initiated by Physicians Total Care, Inc. on June 17, 2013 for the product Drug. The FDA reported the reason for recall as presence of foriegn substance. The product was distributed in GA and the recall is currently terminated.

Recall Number: D-826-2013

Reason for Recall
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
Initiated
06-17-2013
Reported
08-07-2013
Quantity
270 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65601
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.
GA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2013
Product Description About Product Description
Full technical description of the product.
Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only, Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146.

Batch or Lot Expiration Information

Lot# 6GP2; Exp 10/14 West-Ward Lot /WWCN 67331A