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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

RemedyRepack Inc.: Nitrofurantoin Capsules Recalled for Potential Cross-Contamination

Agency Publication Date: November 27, 2018
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Summary

RemedyRepack Inc. is recalling 3,148 units of Nitrofurantoin Monohydrate/Macrocrystals (100 mg) capsules due to potential cross-contamination with unrelated medications, including Benazepril, Haloperidol, and Perphenazine. These prescription capsules were repackaged into HDPE bottles and distributed to two medical facilities in Pennsylvania. Consumers should immediately contact their healthcare provider or pharmacist if they believe they have received this affected medication, as it may contain unintended active ingredients. Because this is a prescription drug recall, you should return any unused product to your pharmacy for a refund and seek medical advice regarding a replacement prescription.

Risk

The presence of unrelated drug ingredients like Benazepril (blood pressure medication), Haloperidol (antipsychotic), or Perphenazine (antipsychotic) can cause unintended side effects, drug interactions, or accidental overdose of medications not prescribed to the patient.

What You Should Do

  1. Check your prescription bottle for Nitrofurantoin Monohydrate/Macrocrystals capsules (100 mg) repackaged by RemedyRepack.
  2. Verify if your medication matches one of the following affected lot numbers and expiration dates: Lot B0484872-081718 (Exp 08/2019), Lot B0481339-081018 (Exp 08/2019), Lot B0506246-092718 (Exp 09/2019), or Lot B0509938-100418 (Exp 10/2019).
  3. Confirm the NDC numbers on the packaging: look for NDC 70518-1087-00 (14-count bottles) or NDC 70518-1087-01 (10-count bottles).
  4. Contact your healthcare provider or pharmacist immediately to discuss your treatment and arrange for a safe replacement medication.
  5. Return any unused capsules to the pharmacy or medical facility where they were obtained for a refund.
  6. Contact the manufacturer, RemedyRepack Inc., at 625 Kolter Dr Ste 4, Indiana, PA 15701, for further instructions regarding the return of the product.
  7. For additional questions or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Nitrofurantoin Monohydrate/Macrocrystals capsules, 100 mg (14 capsules)
Model:
NDC 70518-1087-00
Original NDC 00185-0122-01
D-0284-2019
Lot Numbers:
B0484872-081718 (Exp 08/2019)
B0481339-081018 (Exp 08/2019)
B0506246-092718 (Exp 09/2019)
B0509938-100418 (Exp 10/2019)
Date Ranges: 08/2019, 09/2019, 10/2019
Product: Nitrofurantoin Monohydrate/Macrocrystals capsules, 100 mg (10 capsules)
Model:
NDC 70518-1087-01
Original NDC 00185-0122-01
D-0284-2019
Lot Numbers:
B0484872-081718 (Exp 08/2019)
B0481339-081018 (Exp 08/2019)
B0506246-092718 (Exp 09/2019)
B0509938-100418 (Exp 10/2019)
Date Ranges: 08/2019, 09/2019, 10/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81638
Status: Resolved
Manufacturer: RemedyRepack Inc.
Sold By: medical facilities
Manufactured In: United States
Units Affected: 3,148 capsules
Distributed To: Pennsylvania

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.