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Recall Observatory FDA recall evidence

Drug product

CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88

D-128-2013

April 24, 2012

Class III

Product summary

Firm
Teva Pharmaceuticals USA, Inc.
Event
Event 61725
Status
Terminated
Classification
Class III
Quantity
13,232 bottles
Official record key
drug-enforcement:D-128-2013

Official wording

Reason: Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life

Code information: Lot number 6A007046V, exp 07/12

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life