Nystatin Oral Suspension Recalled Due to CGMP Violation
PAI Holdings is recalling Nystatin Oral Suspension nationwide due to a lack of Current Good Manufacturing Practice (CGMP) controls that could allow carryover of Senna Syrup into the product.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing control deficiency (potential carryover) that poses a theoretical risk; the source does not describe actual harm or hospitalization reports. This falls under the Moderate category for precautionary recalls with manufacturing or labeling deficiencies.
Plain-English summary
PAI Holdings, LLC dba Pharmaceutical Associates Inc is recalling Nystatin Oral Suspension, USP 100,000 units per mL in Cherry/Peppermint Flavor. The recall affects two package sizes: 16 fl oz (473 mL) bottles in NDC 0121-0868-16 and 2 fl oz (60 mL) bottles in NDC 0121-0868-02, distributed nationwide in the USA.
The recall is being conducted due to a lack of Current Good Manufacturing Practice (CGMP) controls. Specifically, there is potential for carryover of Senna Syrup into the Nystatin product during manufacturing.
Affected lot numbers are: C98F, C990 (expiration 30SEP2022), and C9C2 (expiration 31OCT2022) for the 16 fl oz bottles; and C9E1 (expiration 31OCT2022) for the 2 fl oz bottles.
Consumers in possession of affected product should stop using it and contact their pharmacy or healthcare provider for guidance. Healthcare providers and patients should report any adverse reactions to the FDA's MedWatch program at 1-888-SAFEFDA or online at fda.gov/medwatch.
The recalled product
- Product
- NYSTATIN (NYSTATIN)
- Brand
- NYSTATIN
- Manufacturer
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Hazard
- manufacturing-defect
- foreign-substance-carryover
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 (4)
- Lots: a) C98F
- C990 Exp. 30SEP2022
- C9C2 Exp. 31OCT2022
- b) C9E1 Exp. 31OCT2022
UPCs (1)
- 0301210868023
Distribution
Distributed nationwide across the United States.
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