Drug 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
D-924-2013
Product summary
- Event
- Event 65912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9003 Bottles
- Official record key
drug-enforcement:D-924-2013
Official wording
Reason: 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.
Code information: Lot #: 6A301029, Exp 1/2016; 6A303025, Exp. 3/2016
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.