Recalls / Class III
Class IIID-128-2013
Product
CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88
- Brand name
- Cabergoline
- Generic name
- Cabergoline
- Active ingredient
- Cabergoline
- Route
- Oral
- NDC
- 0093-5420
- FDA application
- ANDA077750
- Affected lot / code info
- Lot number 6A007046V, exp 07/12
Why it was recalled
Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, N/A, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 13,232 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-04-24
- FDA classified
- 2013-01-16
- Posted by FDA
- 2013-01-23
- Terminated
- 2013-12-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-128-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.