Taro Recalls Nystatin and Triamcinolone Acetonide Cream for Stability Failures
Taro Pharmaceuticals is recalling Nystatin and Triamcinolone Acetonide Cream because it failed content uniformity specifications during 18-month stability testing.
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 due to out-of-specification stability results, which fits the rubric for moderate severity involving potential but not confirmed serious harm.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is recalling Nystatin and Triamcinolone Acetonide Cream, USP, in 15-gram, 30-gram, and 60-gram tubes. The recall involves 278,304 tubes distributed nationwide and in Puerto Rico. The product is a prescription topical cream containing 100,000 USP nystatin units and 1 mg triamcinolone acetonide.
The recall was initiated because the product failed Content Uniformity Specifications, resulting in out-of-specification (OOS) results during 18-month stability testing. The affected lots include B505118501 (15 g), B504918500 (30 g), I416616979 (60 g), I416716979 (60 g), and D504519119 (60 g). These lots have expiration dates ranging from August 2017 to March 2018.
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 FDA classifies this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN AND TRIAMCINOLONE ACETONIDE)
- Brand
- NYSTATIN AND TRIAMCINOLONE ACETONIDE
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Affected units
- 278,304
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 (8)
- a) 15 g: Lot B505118501
- exp. date January 2018
- b) 30 g: Lot B504918500
- c) 60 g: Lots: I416616979
- exp. date August 2017
- I416716979
- exp. date August 2017 and D504519119
- exp. date March 2018
Distribution
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