Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot #: 6A301029, Exp 1/2016; 6A303025, Exp. 3/2016
Why it was recalled
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.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 9003 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-08-06
- FDA classified
- 2013-08-27
- Posted by FDA
- 2013-09-04
- Terminated
- 2014-08-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-924-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.