The Recall Desk
LowFDA (Drugs)·D-0262-2019·Announced 2018-11-21

Sandoz Recalls Nitrofurantoin Capsules Due to Cross-Contamination

Sandoz Inc. is recalling specific lots of Nitrofurantoin Capsules 100 mg due to cross-contamination with other products.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.

Plain-English summary

Sandoz Inc. is recalling 23,053 bottles of Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottles. The product is manufactured for Northstar Rx LLC and is available by prescription only. The recall is being conducted due to cross-contamination with other products.

The affected product is identified by NDC 16714-439-01. The specific lots involved are JA7319, JA7320, and JA7321, all with an expiration date of 03/2020. The recall covers distribution nationwide within the United States.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this medication.

The recalled product

Product
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01
Manufacturer
Sandoz Inc
Category
Drug — Antibiotic
Hazard
Affected units
23,053

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)

  • Lot #: JA7319
  • JA 7320
  • JA7321
  • Exp. 03/2020

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.

See all 6 products in this recall →

Related recalls

Same manufacturer · Sandoz Inc

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Same hazard · cross contamination

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