Recalls / Class II
Class IID-0474-2017
Product
Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30
- Brand name
- Venlafaxine Hydrochloride
- Generic name
- Venlafaxine Hydrochloride
- Active ingredient
- Venlafaxine Hydrochloride
- Route
- Oral
- NDCs
- 65862-527, 65862-528, 65862-697
- FDA application
- ANDA200834
- Affected lot / code info
- Lot #: VI3716010-A, Exp. 04/2018
Why it was recalled
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Ste 210, N/A, Plainsboro, New Jersey 08536-3004
Distribution
- Quantity
- 47,040 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2016-12-22
- FDA classified
- 2017-02-13
- Posted by FDA
- 2017-02-22
- Terminated
- 2019-03-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0474-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.