FDA recall D-924-2013

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

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-08-06

Report date

2013-09-04

Termination date

2014-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-924-2013