D-0273-2019 Class III Terminated
FDA drug recall D-0273-2019 was initiated by AMERICAN HEALTH PACKAGING on Nov 9, 2018 and is designated Class III. 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… The recall status is terminated (terminated Sep 30, 2020). Affected quantity: 4508 blister packs.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 28, 2018
- Initiation Date
- Nov 9, 2018
- Termination Date
- Sep 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0273-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026