Why it was recalled
Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
Product description
Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30
Lot numbers, UPCs & expiration codes
Lot # A00984 Exp. 01/14
Where it was sold
GA and TN.
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-051-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 23, 2012
- FDA report date
- Nov 21, 2012
- Quantity
- 5 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Stat Rx USA
Original FDA data
Every field from FDA enforcement report D-051-2013, exactly as published.
Show all FDA fields
- City
- Gainesville
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 63659
- Address
- 2481 Hilton Dr
- Code information
- Lot # A00984 Exp. 01/14
- Postal code
- 30501-6213
- Report date
- Nov 21, 2012
- Product type
- Drugs
- Recall number
- D-051-2013
- Classification
- Class III
- Recalling firm
- Stat Rx USA
- Product quantity
- 5 bottles
- Termination date
- Jan 31, 2013
- Reason for recall
- Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30
- Distribution pattern
- GA and TN.
- Recall initiation date
- Aug 23, 2012
- Initial firm notification
- Center classification date
- Nov 9, 2012