Diflorasone Diacetate Ointment recalled for foreign particles
Teligent Pharma is recalling Diflorasone Diacetate Ointment USP 0.05% due to the presence of foreign particles found during routine stability testing. The recall affects 6,240 tubes distributed nationwide.
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 stated in the source text. The hazard—foreign particles—is a contamination issue without evidence of actual harm to patients, making it a precautionary recall that meets the Moderate severity threshold.
Plain-English summary
Teligent Pharma, Inc. is recalling Diflorasone Diacetate Ointment USP, 0.05%, packaged in 15 g (NDC 52565-063-15) and 30 g (NDC 52565-063-30) tubes. This is a prescription medication manufactured by Teligent Pharma, Inc. in Buena, NJ.
The recall was initiated due to the presence of foreign particles observed during routine stability testing. Approximately 6,240 tubes from Lot #16264 (with an expiration date of November 2022) were distributed nationwide in the United States.
Consumers who have received this product should contact their pharmacy or healthcare provider. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical / Corticosteroid
- Hazard
- foreign-particles
- contamination
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 #: 16264
- Exp Date Nov 2022
Distribution
Distributed nationwide across the United States.
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