FDAFDA · Food and drugs·Recall number D-1415-2014
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.
Published July 9, 2014 · Recall initiated: June 12, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Caraco Pharmaceutical Laboratories, Ltd.
- Distributor
- Nationwide including Puerto Rico
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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