The Recall Desk
LowFDA (Drugs)·D-1678-2012·Announced 2012-09-26

Sandoz Recalls Pramipexole Dihydrochloride Tablets Due to Impurity

Sandoz Incorporated is recalling specific lots of Pramipexole Dihydrochloride Tablets because stability testing revealed an out-of-specification impurity.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Sandoz Incorporated is recalling Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count bottles. The recall involves 41,761 bottles distributed nationwide. The affected lots are KW10J511, KW10J512, KW10J513, KW10J514, KW10J515, BJ3167, BJ3172, BJ3177, BJ3179, BJ3188, and BJ3182, all with an expiration date of 09/12.

The recall was initiated because an out-of-specification result for a known impurity was detected during 12-month stability testing. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or supplier for disposal or replacement.

The recalled product

Product
Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92
Manufacturer
Sandoz Incorporated
Category
Drug — Prescription Medication
Hazard
Affected units
41,761

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • Lot numbers: KW10J511
  • KW10J512
  • KW10J513
  • KW10J514
  • KW10J515
  • BJ3167
  • BJ3172
  • BJ3177
  • BJ3179
  • BJ3188
  • BJ3182. Exp. 09/12

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Sandoz Incorporated under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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