D-0273-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 28, 2018
- Initiation Date
- November 9, 2018
- Termination Date
- September 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4508 blister packs
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)
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."
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot#: 180310, 180612, Exp 03/31/20