Why it was recalled
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Product description
Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90
Lot numbers, UPCs & expiration codes
Lot #: GS011692, GS011938, Exp 10/2017; GS012638, GS012639, Exp 11/2017
Where it was sold
Nationwide
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-1459-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 3, 2016
- FDA report date
- Aug 24, 2016
- Quantity
- 40,631 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-1459-2016, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 74847
- Address
- 5187 Camino Ruiz
- Code information
- Lot #: GS011692, GS011938, Exp 10/2017; GS012638, GS012639, Exp 11/2017
- Postal code
- 93012-8601
- Report date
- Aug 24, 2016
- Product type
- Drugs
- Recall number
- D-1459-2016
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- 40,631 bottles
- Termination date
- Feb 2, 2017
- Reason for recall
- Failed Dissolution Specifications: Out-of-specification results in retained sample.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 3, 2016
- Initial firm notification
- Letter
- Center classification date
- Aug 16, 2016