The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1677-2012·Announced 2012-09-26

Sandoz Recalls Pramipexole Dihydrochloride Tablets Due to Impurity

Sandoz Incorporated is recalling Pramipexole Dihydrochloride Tablets, 0.25 mg, because an out-of-specification result for a known impurity occurred during stability testing.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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

Our severity reasoning: The recall is classified as FDA Class III, 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, 0.25 mg, 90-count bottles. The recall involves 43,060 bottles distributed nationwide. The affected lot numbers are BJ3338, BJ3339, BJ 3340, BJ3341, BJ3342, BJ6282, BJ7192, BM8498, BJ7202, and BJ7203, all with an expiration date of 12/12.

The recall was initiated because an out-of-specification result for a known impurity of the product occurred during 12-month stability testing. The agency has classified this recall as Class III.

Consumers and healthcare providers should stop using the affected tablets and contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment options.

The recalled product

Product
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,
Manufacturer
Sandoz Incorporated
Category
Drug — Prescription Medication
Hazard

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: BJ3338
  • BJ3339
  • BJ 3340
  • BJ3341
  • BJ3342
  • BJ6282
  • BJ7192
  • BM8498
  • BJ7202
  • BJ7203
  • Exp 12/12

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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