Alvogen Recalls Nitrofurantoin Capsules Due to Failed Dissolution Test
Alvogen, Inc. is recalling Nitrofurantoin Monohydrate/Macrocrystalline capsules because they failed a dissolution specification test.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a failure to meet dissolution specifications, which is a quality defect rather than a direct contamination or acute injury risk.
Plain-English summary
Alvogen, Inc. is recalling 13,392 bottles of Nitrofurantoin Monohydrate/Macrocrystalline capsules, 100 mg, 100 count. The product is distributed nationwide and in Puerto Rico. The specific lot affected is Lot 457529, with an expiration date of 08/2016.
The recall was initiated because the product failed a dissolution specification test at the 6-month time point. This means the capsules may not release the medication in the body as intended.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or physician for guidance on alternative treatment options.
The recalled product
- Product
- NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE)
- Brand
- NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE
- Manufacturer
- Alvogen, Inc
- Category
- Drug — Antibiotic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 457529
- exp. 08/2016
UPCs (1)
- 0347781303013
Distribution
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