Recall: D-0474-2017

Class II - Potentially Harmful

Class IIClassification

2016-12-22Initiated

TerminatedStatus

Aurobindo Pharma USA IncFirm

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

Reason

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

Distribution

Nationwide in the US

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.