Nystatin Oral Suspension Recalled for Low Potency
Pharmaceutical Associates, Inc. is recalling Nystatin Oral Suspension because it tested below the required potency level.
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 recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is subpotency, which is a lower risk than contamination or serious injury.
Plain-English summary
Pharmaceutical Associates, Inc. is recalling Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottles. The recall is due to low out-of-specification results for assay testing, meaning the product may not contain the full amount of the active ingredient required by the United States Pharmacopeia.
The affected product is identified by Lot BE85 with an expiration date of 11/2020. A total of 7,416 bottles were distributed nationwide in the United States. The product is a prescription-only medication used to treat fungal infections.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- NYSTATIN (NYSTATIN)
- Brand
- NYSTATIN
- Category
- Drug — Antifungal
- Hazard
- Affected units
- 7,416
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 (2)
- Lot: BE85
- Exp. 11/2020
UPCs (1)
- 0301210810022
Distribution
Distributed nationwide across the United States.
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