Drug product
Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), 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-1283-2014
Product summary
- Event
- Event 67784
- Status
- Terminated
- Classification
- Class II
- Quantity
- 160,105 bottles
- Official record key
drug-enforcement:D-1283-2014
Official wording
Reason: Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Code information: Lot #: a) JKL3354A, Exp 04/14; JKL5444A, Exp 08/14; JKL5457B, JKL5445A, Exp 09/14; JKL5840A, Exp 10/14; JKL6588A, Exp 11/14; b) JKL3354B, Exp 04/14; JKL5444B, Exp 08/14; JKL5457C, JKL5445B, Exp 09/14; JKL5840B, Exp 10/14.
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications