Class II · Moderate risk
Nitrofurantoin Capsules
Failed Dissolution Specifications
Nitrofurantoin Monohydrate/Macrocrystals capsules
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
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 trays & HDPE 60 cc bottles in plastic bags, Repackaged NDC 70518-1087-01, 10 capsules in HDPE 60 cc bottles in cardboard trays.
Affected NDCs
0185-0122
70518-1087-00
70518-1087-01
Compare with the code on your package — it is the most precise check available.
Drug: Nitrofurantoin
Product details
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Nitrofurantoin (monohydrate/macrocrystals) NDC 00185-0122 |
NITROFURANTOIN MONOHYDRATE 75 mg/1; NITROFURANTOIN 25 mg/1 | Capsule Oral |
Sandoz Inc | Rx |
| Nitrofurantoin (monohydrate/macrocrystals) NDC 70518-1087 |
NITROFURANTOIN MONOHYDRATE 75 mg/1; NITROFURANTOIN 25 mg/1 | Capsule Oral |
Remedyrepack INC. | Rx |
- Recalling firm
- RemedyRepack Inc.
- NDC code
- 00185-0122-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0284-2019 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Nitrofurantoin recalls
See all
Class II · Moderate risk
Nitrofurantoin Capsules
Failed Dissolution Specifications
Class III · Low risk
Nitrofurantoin Capsules
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Class II · Moderate risk
Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Nitrofurantoin Capsules USP
Failed Dissolution Specifications
Other recalls by RemedyRepack Inc.
All 2018 recalls
Class II · Moderate risk
Clindamycin HCl Capsule
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class II · Moderate risk
Clindamycin HCl
CGMP Deviations
Class II · Moderate risk
Carvedilol 25 mg Tablet
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
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