Betamethasone Dipropionate Ointment USP recall: Impurity Out of Spec
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
Why was Betamethasone Dipropionate Ointment USP recalled?
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 14297, Exp 9/2021; 15372, Exp 3/2022; 15841, Exp 8/2022
- Product
- Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
- Recalling firm
- Teligent Pharma, Inc.
- Quantity
- 104,784 tubes
- Distribution
- USA Nationwide
- Recall date
- May 5, 2021
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)