FDA recall D-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.

Reason for recall

Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.

Distribution

Nationwide including Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-06-12

Report date

2014-07-09

Termination date

2015-05-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Detroit, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1415-2014