Pharmaceutical Associates Recalls Nystatin Oral Suspension Due to Resuspension Issues
Pharmaceutical Associates Inc. is recalling Nystatin Oral Suspension because the product failed to meet specifications for appearance and resuspendability.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The issue is a quality defect (resuspension) rather than a direct safety hazard like contamination or mislabeling.
Plain-English summary
Pharmaceutical Associates Inc. is recalling Nystatin Oral Suspension, USP, 500,000 units/5 mL, packaged in 5 mL cups. The product is intended for institutional use only and is available by prescription. The recall involves 275,400 cups distributed nationwide.
The recall was initiated because the product was found to be out of specification for appearance and resuspendability. This means the medication may not mix properly when shaken, which could affect the consistency of the dose.
The affected lot is B5B8 with an expiration date of 07/2019. The NDC number is 0121-4810-05. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the manufacturer for further instructions.
The recalled product
- Product
- NYSTATIN (NYSTATIN)
- Brand
- NYSTATIN
- Manufacturer
- Pharmaceutical Associates Inc
- Category
- Drug — Antifungal
- Hazard
- Affected units
- 275,400
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 (1)
- Lot: B5B8 Exp. 07/2019
UPCs (1)
- 0301210810022
Distribution
Distributed nationwide across the United States.
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