Diflorasone Diacetate Ointment USP 0.05% Nationwide Recall
Teligent Pharma is recalling all unexpired batches of Diflorasone Diacetate Ointment USP 0.05% nationwide due to cGMP deviations related to discontinuation of the stability study program.
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 procedural cGMP deviation (discontinuation of stability testing) rather than a confirmed product defect or contamination, making it a precautionary recall typical of Moderate severity.
Plain-English summary
Teligent Pharma, Inc. is recalling all unexpired Diflorasone Diacetate Ointment USP, 0.05%, in 60 g tubes (NDC 52565-063-60) distributed nationwide in the USA and Puerto Rico. The recall affects batches 15876 (expiration 8/31/2022) and 16205 (expiration 11/30/2022), plus all other products within expiry.
The recall is being issued because Teligent Pharma is discontinuing its stability study program, which constitutes a deviation from current Good Manufacturing Practice (cGMP) requirements.
Patients currently using this medication should contact their healthcare provider or pharmacist for guidance. Healthcare providers and pharmacies should quarantine remaining stock and return it to the manufacturer.
The recalled product
- Product
- Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent Pharm, Inc., Buena, New Jersey 08310, NDC 52565-063-60.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- cgmp-deviation
- stability-testing-discontinued
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)
- Batch: 15876
- Exp 8/31/2022
- 16205
- Exp. 11/30/2022
Distribution
Distributed nationwide across the United States.
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