Why it was recalled
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Product description
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.
Lot numbers, UPCs & expiration codes
30 Count Bottle: Lot #: JKL5054A, Expiry: 08/2014; Lot #: JKM2305A, Expiry: 03/2015. 90 Count Bottle: Lot #: JKL5054B, Expiry: 08/2014; Lot #: JKM2305B, Expiry: 03/2015.
Where it was sold
Nationwide including 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-1415-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 12, 2014
- FDA report date
- Jul 9, 2014
- Quantity
- 26,530 30-Count Bottles; 14,597 90-Count Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
Original FDA data
Every field from FDA enforcement report D-1415-2014, exactly as published.
Show all FDA fields
- City
- Detroit
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 68637
- Address
- 1150 Elijah McCoy Dr
- Code information
- 30 Count Bottle: Lot #: JKL5054A, Expiry: 08/2014; Lot #: JKM2305A, Expiry: 03/2015. 90 Count Bottle: Lot #: JKL5054B, Expiry: 08/2014; Lot #: JKM2305B, Expiry: 03/2015.
- Postal code
- 48202-3344
- Report date
- Jul 9, 2014
- Product type
- Drugs
- Recall number
- D-1415-2014
- Classification
- Class II
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
- Product quantity
- 26,530 30-Count Bottles; 14,597 90-Count Bottles
- Termination date
- May 6, 2015
- Reason for recall
- Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide including Puerto Rico
- Recall initiation date
- Jun 12, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 2, 2014