FDAClass IIIJanuary 23, 2013

CABERGOLINE Tablets recall: Impurity Out of Spec

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

Why was CABERGOLINE Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number 6A007046V, exp 07/12

Product
CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88
Recalling firm
Teva Pharmaceuticals USA, Inc.
Quantity
13,232 bottles
Distribution
Nationwide
Recall date
January 23, 2013
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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