FDA-Drug2014-07-09Class II
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.
Caraco Pharmaceutical Laboratories, Ltd.
Hazard
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Sold states
Nationwide including Puerto Rico
Affected count
26,530 30-Count Bottles; 14,597 90-Count Bottles
Manufactured in
1150 Elijah McCoy Dr, Detroit, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1415-2014Don't want to check this manually?
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