Pramipexole Dihydrochloride Tablets recall: Contamination
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
Why was Pramipexole Dihydrochloride Tablets recalled?
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot, expiry: Lot 172669, exp 05/31/2019; Lots 175872, 177086, exp 09/30/2019; Lot 179047, exp 12/31/2019; Lot 182584, exp 07/31/2020
- Product
- 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
- Recalling firm
- American Health Packaging
- Quantity
- 16,698 cartons
- Distribution
- Nationwide USA
- Recall date
- July 3, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)