Key Takeaway

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 by Aurobindo Pharma USA Inc was recalled on December 22, 2016. The hazard: Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.

FDA Drug 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

Recalled: December 22, 2016 ~47,040 bottles units affected D-0474-2017

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

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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

Drugs

Company Information

Aurobindo Pharma USA Inc

Plainsboro, NJ, United States

View all 58 recalls by Aurobindo Pharma USA Inc →

Distribution

Nationwide in the US

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