Recalls / Class II

Class IID-1283-2014

Product

Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), 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.

Affected lot / code info

Lot #: a) JKL3354A, Exp 04/14; JKL5444A, Exp 08/14; JKL5457B, JKL5445A, Exp 09/14; JKL5840A, Exp 10/14; JKL6588A, Exp 11/14; b) JKL3354B, Exp 04/14; JKL5444B, Exp 08/14; JKL5457C, JKL5445B, Exp 09/14; JKL5840B, Exp 10/14.

Why it was recalled

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

Recalling firm

Firm

Caraco Pharmaceutical Laboratories, Ltd.

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

1150 Elijah McCoy Dr, Detroit, Michigan 48202-3344

Distribution

Quantity

160,105 bottles

Distribution pattern

Nationwide and Puerto Rico

Timeline

Recall initiated

2014-03-20

FDA classified

2014-04-29

Posted by FDA

2014-05-07

Terminated

2015-02-24

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1283-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.