RemedyRepack Recalls Nitrofurantoin Capsules Due to Cross-Contamination
RemedyRepack Inc. is recalling specific lots of Nitrofurantoin Monohydrate/Macrocrystals capsules due to potential cross-contamination with unrelated ingredients.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for minor or theoretical risks.
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…
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Antibiotic
- 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.
Lot numbers (7)
- Lot #: B0484872-081718
- B0481339-081018
- Exp 08/2019
- B0506246-092718
- Exp 09/2019
- B0509938-100418
- Exp 10/2019
Distribution
Distributed in 1 state:
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