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.
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 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.
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