The Recall Desk
ModerateFDA (Drugs)·D-1082-2015·Announced 2015-05-20

Alvogen Recalls Nitrofurantoin Capsules Due to Failed Dissolution Test

Alvogen, Inc. is recalling Nitrofurantoin Monohydrate/Macrocrystalline capsules because they failed a dissolution specification test.

What this means for you

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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same brand · NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE

Same manufacturer · Alvogen, Inc

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Same hazard · dissolution failure

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