Alvogen Recalls Macrobid Nitrofurantoin Due to Failed Dissolution Specifications
Alvogen, Inc. is recalling 4,272 bottles of Macrobid (nitrofurantoin monohydrate/macrocrystalline) 100 mg tablets because they failed dissolution specifications.
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 source text does not report any illnesses or injuries, fitting the criteria for a moderate severity rating.
Plain-English summary
Alvogen, Inc. is recalling 4,272 bottles of Macrobid (nitrofurantoin monohydrate/macrocrystalline) 100 mg tablets. The product is a prescription-only urinary tract antibacterial manufactured by Norwich Pharmaceuticals, Inc. and distributed by Almatica Pharma, Inc.
The recall was initiated because the affected product failed to meet dissolution specifications. The specific lot number is 472990, with an expiration date of 03/2020. The National Drug Code (NDC) for the recalled product is 52427-285-01.
The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- MACROBID (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE)
- Brand
- MACROBID
- Manufacturer
- Alvogen, Inc
- Category
- Drug — Prescription Antibiotic
- Hazard
- Affected units
- 4,272
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 # 472990
- Exp 03/2020
UPCs (1)
- 0352427285011
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Alvogen, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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