Recalls / Class II
Class IID-202-2013
Product
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.
- Brand name
- Venlafaxine
- Generic name
- Venlafaxine
- Active ingredient
- Venlafaxine Hydrochloride
- Route
- Oral
- NDCs
- 68382-018, 68382-019, 68382-020, 68382-021, 68382-101
- FDA application
- ANDA077653
- Affected lot / code info
- Lot #: MM8490, Exp 09/14
Why it was recalled
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 13,320 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2013-03-05
- FDA classified
- 2013-03-25
- Posted by FDA
- 2013-04-03
- Terminated
- 2015-05-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-202-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.