Class II · Moderate risk Ongoing
Nitrofurantoin Capsules
Reason Failed Dissolution Specifications
Nitrofurantoin Oral Suspension
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications
What was recalled
Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32
- Recalling firm
- Nostrum Laboratories, Inc.
- NDC code
- 57664-239-32
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1030-2016
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
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Nitrofurantoin Capsules
Reason 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 Terminated
Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Nitrofurantoin Capsules USP
Reason Failed Dissolution Specifications
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