Boehringer Ingelheim Recalls Mirapex Tablets Due to Low Weight
Boehringer Ingelheim is recalling 112 cartons of Mirapex 1 mg tablets because routine stability testing identified low-weight tablets.
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 indicates the product is not likely to cause adverse health consequences, and the issue is a specification failure (low weight) rather than a direct safety hazard like contamination.
Plain-English summary
Boehringer Ingelheim Pharmaceuticals, Inc. is recalling 112 folding cartons of Mirapex (pramipexole dihydrochloride) Tablets, 1 mg. The product is distributed nationwide in the USA and is identified by Lot # AA3280A with an expiration date of SEP 2019.
The recall was initiated because routine stability testing identified low-weight tablets, which failed to meet tablet specifications. The agency has classified this recall as Class III.
Consumers and healthcare providers with this specific lot of Mirapex should stop using the product and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- 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.
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 112
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 (2)
- Lot # AA3280A
- Exp SEP 2019
Distribution
Distributed nationwide across the United States.
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