PlainRecalls
FDA Drug Low Class III Terminated

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)

Reported: November 28, 2018 Initiated: November 9, 2018 #D-0273-2019

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."

Details

Recalling Firm
AMERICAN HEALTH PACKAGING
Units Affected
4508 blister packs
Distribution
U.S.A. Nationwide
Location
Columbus, OH

Frequently Asked Questions

What product was recalled? ▼
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). Recalled by AMERICAN HEALTH PACKAGING. Units affected: 4508 blister packs.
Why was this product 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."
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 28, 2018. Severity: Low. Recall number: D-0273-2019.

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