Why it was recalled
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: a) JKL4344A, Exp 07/14; JKL5460A, Exp 10/14; JKL5458A, Exp 11/14; b) JKL4344B, Exp 07/14; JKL5460B, Exp 10/14; JKL5458B, Exp 11/14.
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1284-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 20, 2014
- FDA report date
- May 7, 2014
- Quantity
- 91,777 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
Original FDA data
Every field from FDA enforcement report D-1284-2014, exactly as published.
Show all FDA fields
- City
- Detroit
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 67784
- Address
- 1150 Elijah McCoy Dr
- Code information
- Lot #: a) JKL4344A, Exp 07/14; JKL5460A, Exp 10/14; JKL5458A, Exp 11/14; b) JKL4344B, Exp 07/14; JKL5460B, Exp 10/14; JKL5458B, Exp 11/14.
- Postal code
- 48202-3344
- Report date
- May 7, 2014
- Product type
- Drugs
- Recall number
- D-1284-2014
- Classification
- Class II
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
- Product quantity
- 91,777 bottles
- Termination date
- Feb 24, 2015
- Reason for recall
- Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 20, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 29, 2014