Why it was recalled
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1432-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 13, 2019
- FDA report date
- Jul 3, 2019
- Quantity
- 16,698 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1432-2019, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 82863
- Address
- 2550 John Glenn Ave Ste A
- Code information
- 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
- Postal code
- 43217-1188
- Report date
- Jul 3, 2019
- Product type
- Drugs
- Recall number
- D-1432-2019
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 16,698 cartons
- Termination date
- Sep 30, 2020
- Reason for recall
- GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- May 13, 2019
- Initial firm notification
- Letter
- Center classification date
- Jun 27, 2019