The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0457-2017·Announced 2017-02-08

VistaPharm Recalls Nystatin Oral Suspension Due to Potential Water Contamination

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

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 potential contamination with Burkholderia cepacia, a pathogen associated with serious infections, meeting the criteria for a Severe rating.

Plain-English summary

VistaPharm, Inc. is recalling Nystatin Oral Suspension, USP 100,000 units per mL, in 2 fl. oz. and 16 fl. oz. bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where the purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

The affected products are NDC 66689-008-02 and NDC 66689-008-16. Specific lot numbers and expiration dates are listed in the recall documentation. The recall is classified as FDA Class II.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.

The recalled product

Product
Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Manufacturer
VistaPharm, Inc.
Category
Drug — Antifungal
Hazard
Affected units
67,955

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 (5)

  • a) Lot No. 422600 (Exp. 10/17)
  • 420000 (Exp. 09/17)
  • 416100 (Exp. 08/17)
  • 417400 (Exp. 09/17) b) Lot No. 424200 (Exp. 10/17)
  • 415500 (Exp. 03/18)

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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