Why it was recalled
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Product description
Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
Lot numbers, UPCs & expiration codes
Lot #: 174096, Exp 05/31/19
Where it was sold
Nationwide in the 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-0595-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 19, 2018
- FDA report date
- Feb 21, 2018
- Quantity
- 270 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AMERICAN HEALTH PACKAGING
Original FDA data
Every field from FDA enforcement report D-0595-2018, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 79036
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #: 174096, Exp 05/31/19
- Postal code
- 43217-1188
- Report date
- Feb 21, 2018
- Product type
- Drugs
- Recall number
- D-0595-2018
- Classification
- Class II
- Recalling firm
- AMERICAN HEALTH PACKAGING
- Product quantity
- 270 cartons
- Termination date
- Mar 14, 2019
- Reason for recall
- CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 19, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 13, 2018