Why it was recalled
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Product description
Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]
Lot numbers, UPCs & expiration codes
Lot# 166023 - Exp. 11/30/18 (232 units). Lot# 168467 - Exp. 2/28/19 (1053 units).
Where it was sold
Lot#166023 products distributed from 12/29/16 to 1/19/17 and Lot#168467 distributed from 4/6/17 to 9/11/17. Distributors are the wholesalers who received the product; others are the Corporate Offices for those wholesalers.
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-0915-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 25, 2018
- FDA report date
- Jul 18, 2018
- Quantity
- 1285 cartons (cartons of 100 individual unit doses)
- Recalling firm
- AMERICAN HEALTH PACKAGING
Original FDA data
Every field from FDA enforcement report D-0915-2018, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 80389
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot# 166023 - Exp. 11/30/18 (232 units). Lot# 168467 - Exp. 2/28/19 (1053 units).
- Postal code
- 43217-1188
- Report date
- Jul 18, 2018
- Product type
- Drugs
- Recall number
- D-0915-2018
- Classification
- Class III
- Recalling firm
- AMERICAN HEALTH PACKAGING
- Product quantity
- 1285 cartons (cartons of 100 individual unit doses)
- Termination date
- Apr 29, 2020
- Reason for recall
- Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
- Product description
- Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]
- Distribution pattern
- Lot#166023 products distributed from 12/29/16 to 1/19/17 and Lot#168467 distributed from 4/6/17 to 9/11/17. Distributors are the wholesalers who received the product; others are the Corporate Offices for those wholesalers.
- Recall initiation date
- Jun 25, 2018
- Center classification date
- Jul 9, 2018