Drug Enforcement D-924-2013

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.

Status

Terminated

Classification

Class II

Report Date

September 4, 2013

Termination Date

August 27, 2014

Product Information

Product description
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
Product quantity
9003 Bottles
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.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Teva Pharmaceuticals USA, Inc.
Address
650 Cathill Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-924-2013
Event ID
65912
Recall initiation date
August 6, 2013
Center classification date
August 27, 2013
Code info
Lot #: 6A301029, Exp 1/2016; 6A303025, Exp. 3/2016
More code info