Recalls / Class II
Class IID-1415-2014
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.
- Affected lot / code info
- 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.
Why it was recalled
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Recalling firm
- Firm
- Caraco Pharmaceutical Laboratories, Ltd.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1150 Elijah McCoy Dr, Detroit, Michigan 48202-3344
Distribution
- Quantity
- 26,530 30-Count Bottles; 14,597 90-Count Bottles
- Distribution pattern
- Nationwide including Puerto Rico
Timeline
- Recall initiated
- 2014-06-12
- FDA classified
- 2014-07-02
- Posted by FDA
- 2014-07-09
- Terminated
- 2015-05-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1415-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.