Dr. Reddy's Recalls Nystatin and Triamcinolone Cream for Stability Failures
Dr. Reddy's Laboratories is recalling Nystatin and Triamcinolone Acetonide Cream because stability testing showed out-of-specification results for Nystatin composition.
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm. The recall involves 35,020 tubes distributed nationwide in the United States. The product is available in 15 g, 30 g, and 60 g tubes and is prescription-only.
The recall was initiated because an out-of-specification result was observed for the test parameter of Nystatin composition during stability testing. This indicates that the product may not meet the required stability specifications for the Nystatin ingredient.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions. The specific lot numbers and expiration dates affected are listed in the recall documentation.
The recalled product
- Product
- Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ -
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Topical Cream
- Affected units
- 35,020
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 (19)
- Lot #: a) D06017
- D06018
- Exp 9/18
- D06028 Exp 10/18
- b) D06014
- D06015
- D06016
- D06024
- D06025
- D06026
- D06027
- Exp 10/2018
- c) D06011
- D06012
- D06013
- D06020
- D06021
- D06022
- D06023
Distribution
Distributed nationwide across the United States.
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