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
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
What was recalled
Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, NDC 43386-450-11.
- Recalling firm
- Lupin Somerset
- NDC code
- 43386-450-11
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0346-2019
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
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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