Drug 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
D-0474-2017
Product summary
- Event
- Event 76325
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47,040 bottles
- Official record key
drug-enforcement:D-0474-2017
Official wording
Reason: Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Code information: Lot #: VI3716010-A, Exp. 04/2018
Distribution pattern: Nationwide in the US
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.