Recalls / Class II
Class IID-1461-2016
Product
Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 1000-count bottles, (NDC 68382-035-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.
- Brand name
- Venlafaxine Hydrochloride
- Generic name
- Venlafaxine Hydrochloride
- Active ingredient
- Venlafaxine Hydrochloride
- Route
- Oral
- NDCs
- 68382-034, 68382-035, 68382-036
- FDA application
- ANDA090174
- Affected lot / code info
- Lot #: a) MS1217, MS1218 , Exp.12/2017. Lot #: b) MS1215, Exp.12/2017 Lot #: c) MR11150, MR11151, MR11854, Exp. 10/2017; MR11798, MR11799, MS1214, Exp.11/2017
Why it was recalled
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-07-19
- FDA classified
- 2016-08-18
- Posted by FDA
- 2016-08-24
- Terminated
- 2020-09-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1461-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.