July 2013 FDA Recall Drug by Teva Pharmaceuticals Usa, Inc.
D-842-2013 - Labeling -label error on declared strength
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc. on July 23, 2013 for the product Drug. The FDA reported the reason for recall as labeling -label error on declared strength. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-842-2013
Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules
07-23-2013
08-14-2013
6267 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
08-27-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01
Batch or Lot Expiration Information
Lot# N07321, Exp 6/14
