Lupin Recalls Nystatin and Triamcinolone Acetonide Cream for Stability Failure
Lupin Pharmaceuticals is recalling Nystatin and Triamcinolone Acetonide Cream due to a failed uniformity of containers test. The recall covers 33,939 tubes distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a stability specification failure without reported injuries or illnesses.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Nystatin and Triamcinolone Acetonide Cream USP 100,000 units/g, 0.1%, 15 g tube. The recall involves 33,939 tubes distributed nationwide within the United States. The specific lots affected are K800245 (Exp. Dec 2019), K900036 (Exp. Sep 20), and K900153 (Exp. 09/2020).
The recall was initiated because an out-of-specification result was observed in the uniformity of containers test at the 9-month long-term stability condition for upright orientation. This indicates a failure to meet Content Uniformity Specifications.
Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or point of purchase for a refund or replacement. The product is a prescription-only topical medication manufactured by Lupin Limited in India for Lupin Pharmaceuticals, Inc.
The recalled product
- Product
- NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN AND TRIAMCINOLONE ACETONIDE)
- Brand
- NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Affected units
- 33,939
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)
- Lot #: K800245
- Exp. Dec 2019
- K900036 Exp. Sep 20
- K900153
- Exp. 09/2020
UPCs (1)
- 0368180545033
Distribution
Distributed nationwide across the United States.
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