Clobetasol Propionate Lotion recall due to manufacturing deviations
Teligent Pharma is recalling 35,180 bottles of Clobetasol Propionate Lotion 0.05% nationwide due to manufacturing deviations and discontinued stability testing. No illnesses reported.
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 a Class II voluntary precautionary recall with no reported illnesses or injuries. The recall stems from manufacturing deviations and discontinued stability testing rather than a confirmed hazard. Per the severity rubric, voluntary precautionary recalls are classified as Moderate.
Plain-English summary
Teligent Pharma, Inc. is recalling Clobetasol Propionate Lotion, 0.05%, in 2 fl. oz. (59 mL) and 4 fl. oz. (118 mL) bottles, totaling 35,180 units. The affected products were distributed nationwide in the USA and Puerto Rico.
The recall is due to current Good Manufacturing Practice (cGMP) deviations identified at the manufacturing facility. The firm is also discontinuing its stability study program, meaning it can no longer verify the product maintains its intended safety and effectiveness throughout its shelf life.
Consumers with this medication should contact their healthcare provider or pharmacist for guidance. Do not discontinue use without medical advice, as sudden cessation of prescribed topical corticosteroids may cause adverse effects.
The recalled product
- Product
- Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- manufacturing-deviation
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 (18)
- Batch: a) 15599
- Exp. 4/30/2022
- 16108
- Exp. 10/31/2022
- 16471
- Exp. 2/28/2023
- 16680
- Exp. 3/31/2023
- b) 15120
- 15126
- 15592
- Exp. 2/28/2022
- 15599
- 16145
- 16261
- Exp. 12/31/2022
- 16456
- 16552
Distribution
Distributed nationwide across the United States.
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