Sandoz Recalls Nitrofurantoin Capsules Due to Cross Contamination
Sandoz Inc is recalling specific lots of Nitrofurantoin capsules because they may be cross-contaminated with other products.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which indicates a low risk of adverse health consequences, aligning with the 'Moderate' severity for minor labeling or low-risk contamination issues.
Plain-English summary
Sandoz Inc is recalling Nitrofurantoin (Monohydrate/Macrocrystals) 100 mg capsules due to cross-contamination with other products. The affected product is a prescription-only medication distributed nationwide in the United States.
The recall involves 14,366 bottles, including 100-capsule bottles (NDC 0185-0122-01) and 1,000-capsule bottles (NDC 0185-0122-10). The specific lots affected are JB4952 and JA7322 (expiration 03/2020) and JA7324 (expiration 03/2020).
Consumers and healthcare providers should check their inventory for these specific lot numbers and NDC codes. If the product is found, it should be returned to the pharmacy or Sandoz Inc for disposal or credit.
The recalled product
- Product
- NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS))
- Brand
- NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
- Manufacturer
- Sandoz Inc
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 14,366
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 (4)
- Lots: a) JB4952
- JA7322 Exp. 03/2020
- b) JA7324
- Exp.03/2020
UPCs (1)
- 0301850122011
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Sandoz 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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