FDA recall D-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

Reason for recall

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

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2016-12-22

Report date

2017-02-22

Termination date

2019-03-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0474-2017