The Recall Desk
SevereFDA (Drugs)·D-0461-2017·Announced 2017-02-08

VistaPharm Recalls Nystatin Oral Suspension Due to Water Contamination

VistaPharm is recalling Nystatin Oral Suspension because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a high-risk pathogen (Burkholderia cepacia) in a drug product, meeting the criteria for a Severe rating due to the potential for significant health consequences.

Plain-English summary

VistaPharm, Inc. is recalling Nystatin Oral Suspension, USP 500,000 Units/5 mL. The product is available in 50 and 100 unit dose cups per case and is prescription-only. The recall covers 55,191 unit dose cups distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. The affected lots include various expiration dates ranging from January 2017 to June 2017.

Consumers and healthcare providers should stop using the affected Nystatin Oral Suspension and return it to the pharmacy or point of purchase. Patients should contact their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
Manufacturer
VistaPharm, Inc.
Category
Drug — Antifungal
Hazard
Affected units
55,191

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 (11)

  • a). Lot No. 428900
  • 425600 (Exp. 05/17)
  • 421200 (Exp. 04/17)
  • 413600 (Exp. 02/17)
  • 411500 (Exp. 01/17)
  • 417200 (Exp. 03/17) b). Lot No. 429300 (Exp. 06/17)
  • 426500 (Exp. 05/17)
  • 420600 (Exp. 03/17)
  • 417000 (Exp.03/17)
  • 412900 (Exp. 01/17)
  • 409900 (Exp. 01/17)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by VistaPharm, 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 11 products in this recall →

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