Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity
Teligent Pharma is recalling Betamethasone Dipropionate Ointment 0.05% due to failed impurity specifications. The product is distributed nationwide in 15-gram tubes.
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 agency classified this as an FDA Class III recall, 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), packaged in 15-gram tubes. The product is manufactured by Teligent Pharma, Inc. in Buena, New Jersey, and distributed by McKesson Corporation dba Sky Packaging in Memphis, Tennessee. The specific lot affected is Lot #15644 with an expiration date of 5/2022.
The recall was initiated because the product failed impurity and degradation specifications. Specifically, the product tested out of specification (OOS) for the known impurity Betamethasone 17-propionate. The agency has classified this recall as Class III, which indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences.
The product was distributed nationwide in the United States. Consumers and healthcare providers should check their inventory for this specific NDC (63739-996-15) and lot number. If the product is found, it should be returned to the distributor or disposed of according to local regulations, as directed by the recalling firm.
The recalled product
- Product
- Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
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 5/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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