Halobetasol Propionate Ointment recalled due to cGMP deviations
Teligent Pharma is recalling all unexpired Halobetasol Propionate Ointment 0.05% (21,323 tubes) due to current good manufacturing practice (cGMP) deviations. The firm 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 stems from cGMP deviations and discontinuation of the stability study program, which is a manufacturing/documentation concern rather than an acute safety threat with demonstrated harm.
Plain-English summary
Teligent Pharma, Inc. is recalling Halobetasol Propionate Ointment, 0.05%, in 50-gram tubes (NDC 63739-998-67) distributed nationwide in the USA and Puerto Rico by McKesson Corporation. The recall affects approximately 21,323 tubes with batch numbers 15720 (expiration 6/30/2022), 16449, and 16450 (expiration 2/28/2023).
The recall is due to current good manufacturing practice (cGMP) deviations. The firm is discontinuing its stability study program, which prompted the recall of all products within their expiry dates.
Patients using this medication should contact their healthcare provider or pharmacist for guidance. Consumers should not use recalled product and should return it to their pharmacy or disposal location.
The recalled product
- Product
- Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-998-67.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical corticosteroid
- Affected units
- 21,323
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 (5)
- Batch: 15720
- Exp. 6/30/2022
- 16449
- 16450
- Exp. 2/28/2023
Distribution
Part of a larger recall action
This product is one of 37 recalled by Teligent Pharma, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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