September 2013 FDA Recall Drug by Physicians Total Care, Inc.
D-0239-2015 - Failed Tablet/Capsule Specifications

This Class III drug recall was voluntarily initiated by Physicians Total Care, Inc. on September 11, 2013 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0239-2015

Reason for Recall
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Initiated
09-11-2013
Reported
11-12-2014
Quantity
7,740 pills

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69595
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-04-2015
Product Description About Product Description
Full technical description of the product.
Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00

Batch or Lot Expiration Information

Lot# : 68GA, 68WE, 6A9W, 6AIT, 6ALI, 6936; Exp. 09/13
Lot# : 6BYA, 6CVI, 6FVX, 6CVH, 6D1W, 6DSH, 6E2V, 6E9W; Exp. 10/13
Lot# : 6HO2, 6I1F; Exp. 11/13
Lot# : 6IG5, 6ILV, 6HCE, 6I7B; Exp. 12/13
Lot# : 6TKA, 6TSZ, 6TUO, 6TXT; Exp. 05/14
Lot# : 6V2S, 6WWJ, 6U9L, 6UQP, 6VJM, 6VSS, 6W3J; Exp. 07/14
Lot# : 6WVP, 6XFX, 6Y99; Exp. 08/14
Lot# :6Y7A; Exp. 10/14