Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-982-95; NDC Carton: 68084-982-25
Reported: July 3, 2019 Initiated: May 13, 2019 #D-1434-2019
Product Description
Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-982-95; NDC Carton: 68084-982-25
Reason for Recall
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 6,643 cartons
- Distribution
- Nationwide USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-982-95; NDC Carton: 68084-982-25. Recalled by American Health Packaging. Units affected: 6,643 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-1434-2019.
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