Recalls / Class II
Class IID-1460-2016
Product
Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), 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) MR10518, Exp. 9/2017; MR11051, MR11052, MR11053, MR11054, Exp. 10/2017; MR11403, Exp. 11/2017. Lot #: b) MR10197, MR10195, Exp. 09/2017; MR11482, Exp.10/2017; MR11479, MR11480, MR11481, MR11483, MR11665 Exp. 11/2017. Lot #: c) MR10404, MR10406, MR10521, Exp. 09/2017; MR10744, MR11055, MR11228, MR11287, MR11285, MR11288, MR11289, MR11286, Exp.10/2017; MR11567, 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
- 223,776 bottles
- 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-1460-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.