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.
Reported: March 20, 2019 Initiated: March 7, 2019 #D-0991-2019
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.
Details
- Recalling Firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Units Affected
- 112 folding cartons
- Distribution
- Nationwide in the USA
- Location
- Ridgefield, CT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Boehringer Ingelheim Pharmaceuticals, Inc.. Units affected: 112 folding cartons.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 20, 2019. Severity: Low. Recall number: D-0991-2019.
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