Drug product
Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. 30-Count Bottle NDC: 41616-758-83, 90-Count Bottle: NDC 41616-758-81.
D-1415-2014
Product summary
- Event
- Event 68637
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26,530 30-Count Bottles; 14,597 90-Count Bottles
- Official record key
drug-enforcement:D-1415-2014
Official wording
Reason: Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Code information: 30 Count Bottle: Lot #: JKL5054A, Expiry: 08/2014; Lot #: JKM2305A, Expiry: 03/2015. 90 Count Bottle: Lot #: JKL5054B, Expiry: 08/2014; Lot #: JKM2305B, Expiry: 03/2015.
Distribution pattern: Nationwide including Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications