Recalls / Class III
Class IIID-0340-2021
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
- Affected lot / code info
- Lot #: 15644, Exp 5/2022
Why it was recalled
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, N/A, Buena, New Jersey 08310
Distribution
- Quantity
- N/A
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2021-02-02
- FDA classified
- 2021-04-23
- Posted by FDA
- 2021-05-05
- Terminated
- 2024-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0340-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.