Hydrocortisone Butyrate Lotion Recalled for cGMP Deviations
Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% due to current Good Manufacturing Practice (cGMP) deviations related to the firm's discontinuation of its 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 involving a manufacturing practice deviation. The source text contains no reports of illness, injury, or product failure; the hazard is procedural and precautionary in nature rather than acute. Per the rubric, Class II recalls without reported adverse events typically fall in the Moderate range.
Plain-English summary
Teligent Pharma, Inc. is recalling all unexpired Hydrocortisone Butyrate Lotion, 0.1%, in 4 fl oz (118 mL) bottles (NDC 70512-032-04), manufactured for SOLA Pharmaceuticals. The recall includes batches 16896 and 16897, with an expiration date of 5/31/2023. Approximately 6874 bottles are affected.
The recall is being conducted because the firm is discontinuing its stability study program, which constitutes a deviation from current Good Manufacturing Practice (cGMP) standards. This results in a lack of adequate data to support the continued distribution of the product.
The affected product has been distributed nationwide in the United States and Puerto Rico. This is a prescription-only medication. Patients currently using this product should contact their healthcare provider for guidance before discontinuing use.
The recalled product
- Product
- Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- cgmp-deviation
- stability-data-gap
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)
- Batch: 16896
- 16897 Exp. 5/31/2023
Distribution
Distributed nationwide across the United States.
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