Desonide Ointment Recalled Due to cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Desonide Ointment 0.05% nationwide because the manufacturer is discontinuing its stability study program, a deviation from current good manufacturing practices (cGMP).
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 manufacturing practice deviation rather than a documented contamination or defect, making this a precautionary recall appropriate for a Moderate severity rating.
Plain-English summary
Teligent Pharma, Inc. is recalling Desonide Ointment 0.05% in two package sizes: 15 gram tubes (NDC 52565-038-15) and 60 gram tubes (NDC 52565-038-60). The recall includes 36,426 tubes distributed nationwide in the USA and Puerto Rico.
The recall is issued because the firm is discontinuing its stability study program, which constitutes a deviation from current good manufacturing practices (cGMP). All products within their expiration dates are affected.
Consumers who have received this medication should contact their healthcare provider or pharmacist for guidance. The affected batches and expiration dates are: 15 g tubes (batches 15495 [exp. 4/30/2022], 16955 [exp. 5/31/2023]); 60 g tubes (batches 15249, 15250, 15446 [exp. 3/31/2022], 15495 [exp. 4/30/2022], 16377 [exp. 1/31/2023]).
The recalled product
- Product
- Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- cgmp-violation
- stability-study-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 (11)
- Batch: a) 15495
- Exp. 4/30/2022
- 16955
- Exp. 5/31/2023
- b) 15249
- 15250
- 15446
- Exp. 3/31/2022
- 15495
- 16377
- Exp. 1/31/2023
Distribution
Distributed nationwide across the United States.
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