Betamethasone Dipropionate Ointment 0.05% recalled for manufacturing compliance failures
McKesson Corporation is recalling 55,440 tubes of Betamethasone Dipropionate Ointment 0.05% (Augmented) nationwide due to manufacturing compliance deviations. The recall stems from the manufacturer's discontinuation of its stability study program.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is based on the manufacturer's discontinuation of stability studies, creating a theoretical risk that the product may not maintain its safety and efficacy through the stated expiration date. Per the rubric, a recall with a theoretical hazard and no reported harm scores at most 3.
Plain-English summary
McKesson Corporation is recalling 55,440 tubes of Betamethasone Dipropionate Ointment USP 0.05% (Augmented), manufactured by Teligent Pharma, Inc. The affected lot is 15644, with expiration date 05/31/2022. The product was distributed nationwide in the United States, including Guam and the Northern Mariana Islands.
The recall is issued due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturing firm has discontinued its stability study program, which is required to verify that the medication maintains its specified characteristics through the labeled expiration date.
Patients using this medication should consult with their healthcare provider or pharmacist regarding this recall. Healthcare facilities and dispensers should identify, quarantine, and return all affected units to the distributor.
The recalled product
- Product
- Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram 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 381
- Manufacturer
- McKesson Corporation dba McKesson Drug Company
- Category
- Drug — Topical Steroid
- Hazard
- manufacturing-compliance
- unverified-stability
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)
- Lot: 15644
- Exp.: 05/31/2022
Distribution
Distributed nationwide across the United States.
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