PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 22, 2017 Initiated: December 22, 2016 #D-0474-2017

Product Description

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

Reason for Recall

Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.

Details

Recalling Firm
Aurobindo Pharma USA Inc
Units Affected
47,040 bottles
Distribution
Nationwide in the US
Location
Plainsboro, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Aurobindo Pharma USA Inc. Units affected: 47,040 bottles.
Why was this product recalled?
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 22, 2017. Severity: Moderate. Recall number: D-0474-2017.