Why it was recalled
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Product description
Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-021-01.
Lot numbers, UPCs & expiration codes
Lot #: MM8490, Exp 09/14
Where it was sold
Nationwide.
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-202-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 5, 2013
- FDA report date
- Apr 3, 2013
- Quantity
- 13,320 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-202-2013, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 64604
- Address
- 73 Route 31 N
- Code information
- Lot #: MM8490, Exp 09/14
- Postal code
- 08534-3601
- Report date
- Apr 3, 2013
- Product type
- Drugs
- Recall number
- D-202-2013
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 13,320 bottles
- Termination date
- May 4, 2015
- Reason for recall
- Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-021-01.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Mar 5, 2013
- Initial firm notification
- Letter
- Center classification date
- Mar 25, 2013