Why it was recalled
Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
Product description
CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88
Lot numbers, UPCs & expiration codes
Lot number 6A007046V, exp 07/12
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-128-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 24, 2012
- FDA report date
- Jan 23, 2013
- Quantity
- 13,232 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-128-2013, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 61725
- Address
- 650 Cathill Rd
- Code information
- Lot number 6A007046V, exp 07/12
- Postal code
- 18960-1512
- Report date
- Jan 23, 2013
- Product type
- Drugs
- Recall number
- D-128-2013
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 13,232 bottles
- Termination date
- Dec 18, 2013
- Reason for recall
- Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 24, 2012
- Initial firm notification
- Letter
- Center classification date
- Jan 16, 2013