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Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured ...

FDA Recall #D-1677-2012 — Class III — September 12, 2012

Recall #D-1677-2012 Date: September 12, 2012 Classification: Class III Status: Terminated

Product Description

Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92,

Reason for Recall

Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.

Recalling Firm

Sandoz Incorporated — Broomfield, CO

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

43,060 x 90 count bottles

Distribution

Nationwide

Code Information

Lot numbers: BJ3338; BJ3339; BJ 3340; BJ3341; BJ3342; BJ6282; BJ7192; BM8498; BJ7202; BJ7203, Exp 12/12

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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