RemedyRepack Recalls Nitrofurantoin Capsules Due to Cross-Contamination

Plain-English summary

RemedyRepack Inc. is recalling Nitrofurantoin Monohydrate/Macrocrystals capsules, 100 mg, due to the potential presence of unrelated ingredients. The affected product was originally manufactured by Sandoz Inc. and repackaged by RemedyRepack Inc. in Indiana, PA. The recall involves 3,148 capsules distributed to two medical facilities in Pennsylvania.

The recall is being conducted because of cross-contamination with other products, specifically the potential presence of Benazepril, Haloperidol, and Perphenazine. The affected lots are B0484872-081718 (Exp 08/2019), B0481339-081018 (Exp 08/2019), B0506246-092718 (Exp 09/2019), and B0509938-100418 (Exp 10/2019).

The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and medical facilities should stop using the affected lots and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product

Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repackaged by: RemedyRepack, Indiana, PA, Original NDC 00185-0122-01Repackaged NDC 70518-1087-00, 14 capsules in HDPE 60 cc bottles in cardboard tra

Manufacturer

RemedyRepack Inc.

Category

Drug — Antibiotic

Hazard

• cross-contamination
• foreign-ingredient

Affected units

3,148

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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