FDAFDA · Food and drugs·Recall number D-1283-2014
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.
Published May 7, 2014 · Recall initiated: March 20, 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 release dissolution specifications.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Caraco Pharmaceutical Laboratories, Ltd.
- Distributor
- Nationwide and Puerto Rico
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.