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Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding cart...

FDA Recall #D-0991-2019 — Class III — March 7, 2019

Recall #D-0991-2019 Date: March 7, 2019 Classification: Class III Status: Terminated

Product Description

Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61.

Reason for Recall

Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.

Recalling Firm

Boehringer Ingelheim Pharmaceuticals, Inc. — Ridgefield, CT

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

112 folding cartons

Distribution

Nationwide in the USA

Code Information

Lot # AA3280A, Exp SEP 2019

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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