Class II · Moderate risk Ongoing
Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc…
Reason Failed Dissolution Specifications
Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles…
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).
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.
- Recalling firm
- RemedyRepack Inc.
- NDC code
- 00185-0122-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0284-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Nitrofurantoin recalls
See all
Class II · Moderate risk Terminated
Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories…
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards…
Reason Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results…
Class II · Moderate risk Terminated
Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only…
Reason Failed Dissolution Specifications
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.