Halobetasol Propionate Ointment Recalled for cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Halobetasol Propionate Ointment 0.05% nationwide due to cGMP deviations. The manufacturer is discontinuing 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 with no reported illnesses or injuries. The hazard is procedural—discontinuation of stability testing—rather than a detected contamination or defect. No actual harm has been reported.
Plain-English summary
Teligent Pharma, Inc. is recalling 35,185 tubes of Halobetasol Propionate Ointment 0.05% (50-gram tubes, NDC 70512-033-50) manufactured for SOLA Pharmaceuticals due to current good manufacturing practice (cGMP) deviations. The recall affects all products within expiry date.
The reason for the recall is that the firm is discontinuing its stability study program. Affected batches include: Batch 15128 (Exp. 2/28/2022), Batch 15721 (Exp. 6/30/2022), Batch 16171 (Exp. 10/31/2022), Batch 16819 (Exp. 4/30/2023), and Batch 17124 (Exp. 7/31/2023).
The product has been distributed nationwide in the USA and Puerto Rico. Consumers who have obtained this product should consult their healthcare provider or pharmacist regarding safe alternatives.
The recalled product
- Product
- Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-033-50.
- 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 (10)
- Batch: 15128
- Exp. 2/28/2022
- 15721
- Exp. 6/30/2022
- 16171
- Exp. 10/31/2022
- 16819
- Exp. 4/30/2023
- 17124
- Exp. 7/31/2023
Distribution
Distributed nationwide across the United States.
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