Recalls / Class II
Class IID-1284-2014
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.
- Affected lot / code info
- 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.
Why it was recalled
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Recalling firm
- Firm
- Caraco Pharmaceutical Laboratories, Ltd.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1150 Elijah McCoy Dr, Detroit, Michigan 48202-3344
Distribution
- Quantity
- 91,777 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-03-20
- FDA classified
- 2014-04-29
- Posted by FDA
- 2014-05-07
- Terminated
- 2015-02-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1284-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.