The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1030-2016·Announced 2016-06-22

Nostrum Recalls Nitrofurantoin Oral Suspension for Failed Dissolution Specifications

Nostrum Laboratories is recalling Nitrofurantoin Oral Suspension because it failed to meet dissolution specifications. The recall covers 2,839 bottles distributed nationwide.

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, which typically involves temporary or medically reversible adverse health consequences. The specific defect is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or mislabeling of a high-risk allergen.

Plain-English summary

Nostrum Laboratories, Inc. is recalling Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, 240 mL bottles. The recall is due to the product failing to meet dissolution specifications. The affected product is distributed by Sun Pharmaceutical Industries, Inc., and manufactured by Sun Pharmaceutical Industries, Inc.

The recall involves 2,839 bottles with lot codes BZP0093A, BZP0094A, BZP0095A, BZP0096A, and BZP0097A, all with an expiration date of 02/2017. The product was distributed nationwide. The NDC number for the affected product is 57664-239-32.

Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase for a refund or replacement. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32
Manufacturer
Nostrum Laboratories, Inc.
Category
Drug — Antibiotic
Hazard
Affected units
2,839

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 (6)

  • BZP0093A
  • BZP0094A
  • BZP0095A
  • BZP0096A
  • BZP0097A
  • Exp 02/2017

Distribution

Distributed nationwide across the United States.

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