Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01
Reported: July 3, 2019 Initiated: May 13, 2019 #D-1432-2019
Product Description
Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01
Reason for Recall
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 16,698 cartons
- Distribution
- Nationwide USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01. Recalled by American Health Packaging. Units affected: 16,698 cartons.
Why was this product recalled? ▼
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 3, 2019. Severity: Moderate. Recall number: D-1432-2019.
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