Why it was recalled
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
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
Lot numbers, UPCs & expiration codes
Lot #: VI3716010-A, Exp. 04/2018
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0474-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 22, 2016
- FDA report date
- Feb 22, 2017
- Quantity
- 47,040 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc
Original FDA data
Every field from FDA enforcement report D-0474-2017, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76325
- Address
- 666 Plainsboro Rd Ste 210
- Code information
- Lot #: VI3716010-A, Exp. 04/2018
- Postal code
- 08536-3004
- Report date
- Feb 22, 2017
- Product type
- Drugs
- Recall number
- D-0474-2017
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc
- Product quantity
- 47,040 bottles
- Termination date
- Mar 19, 2019
- Reason for recall
- Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Dec 22, 2016
- Initial firm notification
- Letter
- Center classification date
- Feb 13, 2017