FDA recall D-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.

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-03-20

Report date

2014-05-07

Termination date

2015-02-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Detroit, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1284-2014