Drug product
Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
D-0236-2017
Product summary
- Event
- Event 76077
- Status
- Terminated
- Classification
- Class II
- Quantity
- 96 bottles
- Official record key
drug-enforcement:D-0236-2017
Official wording
Reason: Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Code information: Lot GG1539
Distribution pattern: MS and OH.
Derived failure modes
-
Potency or specification failure
out of specification