Class II · Moderate risk
Nitrofurantoin Capsules
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.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
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.
Affected NDC
43386-0450-11
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 code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Nitrofurantoin NDC 43386-0450 |
25 mg/5mL | Suspension Oral |
Lupin Pharmaceuticals,Inc. | Rx |
- Recalling firm
- Lupin Somerset
- NDC code
- 43386-450-11
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0346-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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
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Class II · Moderate risk
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Class III · Low risk
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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…
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Class II · Moderate risk
Nitrofurantoin Capsules USP
Failed Dissolution Specifications
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