The Recall Desk
ModerateFDA (Drugs)·D-0869-2017·Announced 2017-06-07

VistaPharm Recalls Nystatin Oral Suspension Due to Impurity

VistaPharm is recalling Nystatin Oral Suspension because it contains an impurity peak that exceeds approved specifications.

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 FDA classified this as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The hazard is a failed impurity specification without reported injuries.

Plain-English summary

VistaPharm, Inc. is recalling Nystatin Oral Suspension, USP, 100,000 units/mL. The product is available in 2 fl.oz. (60mL) bottles and 500,000 units/5mL individual unit dose cups. The recall involves approximately 2,208,500 cups and 18,696 bottles.

The recall was initiated because the product failed impurities and degradation specifications. Specifically, the presence of an impurity peak exceeds the approved specification. The affected lots include 431300, 434000, 432500, 462200, 443800, 445500, 460500, and 461500, with expiration dates ranging from 01/2018 to 09/2017.

The product was distributed nationwide in the US and Puerto Rico. Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement or disposal.

The recalled product

Product
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 6
Manufacturer
VistaPharm, Inc.
Category
Drug — Antifungal
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 (12)

  • a) Lot #: 431300
  • Exp. 01/2018
  • b) Lot #: 434000
  • 432500
  • Exp. 07/2017
  • 462200
  • Exp. 02/2018 c) Lot #: 443800
  • 445500
  • Exp. 09/2017
  • 460500
  • 461500
  • Exp. 01/2018.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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