Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurities
Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% due to failed impurities and degradation specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Teligent Pharma, Inc. is recalling Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) in 15 gram and 50 gram tubes. The recall involves Lot 11852 with an expiration date of 08/2020. The product is distributed nationwide.
The recall was initiated because the product failed impurities and degradation specifications. This is classified as an FDA Class III recall, which indicates that the use of or exposure to the product is not likely to cause adverse health consequences.
Patients and healthcare providers should stop using the affected product and contact their pharmacist or physician for a replacement. The recall number is D-1391-2019.
The recalled product
- Product
- Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 9,360
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 11852
- exp date 08/2020
Distribution
Distributed nationwide across the United States.
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