Drug product
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, 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.
D-1284-2014
Product summary
- Event
- Event 67784
- Status
- Terminated
- Classification
- Class II
- Quantity
- 91,777 bottles
- Official record key
drug-enforcement:D-1284-2014
Official wording
Reason: Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Code information: Lot #: a) JKL4344A, Exp 07/14; JKL5460A, Exp 10/14; JKL5458A, Exp 11/14; b) JKL4344B, Exp 07/14; JKL5460B, Exp 10/14; JKL5458B, Exp 11/14.
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications