G & W Clobetasol Propionate Ointment Recalled for Impurity
G & W Laboratories is recalling Clobetasol Propionate Ointment 0.05% due to out-of-specification results for a known impurity.
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 III, which indicates the product is not likely to cause adverse health consequences. The hazard is a chemical impurity without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
G & W Laboratories, Inc. is recalling Clobetasol Propionate Ointment 0.05% because the product failed impurities and degradation specifications. The recall is due to out-of-specification results for Clobetasol Related Compound A, which is a known impurity and degradation product.
The affected product is a prescription-only topical ointment manufactured by G & W Laboratories, Inc. It is packaged in 15 g, 30 g, 45 g, and 60 g tubes. The recall covers 145,284 tubes distributed nationwide.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance. Specific lot numbers and expiration dates are listed in the official recall notice.
The recalled product
- Product
- CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
- Brand
- CLOBETASOL PROPIONATE
- Manufacturer
- G & W Laboratories, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 145,284
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 (19)
- Lot #: a) 1001090
- Exp 8/ 17
- 1002881
- Exp 2/18
- b) 1001086
- 1001154
- Exp 11/ 17
- 1001156
- Exp 9/17
- 1002882
- 1004564
- Exp 7/18
- c) 1001155
- 1004572
- d) 1001158
- 1001159
- Exp 10/17
- 1002884
- Exp 4/18
UPCs (1)
- 0307130656313
Distribution
Distributed nationwide across the United States.
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