Drug product
Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9
D-160-2013
Product summary
- Event
- Event 63908
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 bottles
- Official record key
drug-enforcement:D-160-2013
Official wording
Reason: Failed Dissolution Test Requirements
Code information: Lot #308198, Expiration Date is 03/2014
Distribution pattern: FL, NJ.
Derived failure modes
-
Unknown
Failed Dissolution Test Requirements