August 2013 FDA Recall Drug by Teva Pharmaceuticals Usa, Inc.
D-924-2013 - Failed Tablet/Capsule Specification

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc. on August 6, 2013 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-924-2013

Reason for Recall
Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.
Initiated
08-06-2013
Reported
09-04-2013
Quantity
9003 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65912
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.
Teva Pharmaceuticals USA, 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.
08-27-2014
Product Description About Product Description
Full technical description of the product.
Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03

Batch or Lot Expiration Information

Lot# : 6A301029, Exp 1/2016; 6A303025, Exp. 3/2016