Why it was recalled
Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."
Product description
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-446-01 (Individual Dose NDC: 68064-446-11)
Lot numbers, UPCs & expiration codes
Lot#: 180310, 180612, Exp 03/31/20
Where it was sold
U.S.A. Nationwide
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-0273-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 9, 2018
- FDA report date
- Nov 28, 2018
- Quantity
- 4508 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AMERICAN HEALTH PACKAGING
Original FDA data
Every field from FDA enforcement report D-0273-2019, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 81553
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot#: 180310, 180612, Exp 03/31/20
- Postal code
- 43217-1188
- Report date
- Nov 28, 2018
- Product type
- Drugs
- Recall number
- D-0273-2019
- Classification
- Class III
- Recalling firm
- AMERICAN HEALTH PACKAGING
- Product quantity
- 4508 blister packs
- Termination date
- Sep 30, 2020
- Reason for recall
- Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-446-01 (Individual Dose NDC: 68064-446-11)
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Nov 9, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 20, 2018