FDA recall D-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

Reason for recall

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2021-02-02

Report date

2021-05-05

Termination date

2024-08-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buena, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0340-2021