FDA recall D-0636-2021

Product

Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.

Reason for recall

Presence of Foreign Substance: Foreign particles observed during routine stability testing.

Distribution

Nationwide in the United States

Key facts

Status

Terminated

Initiation date

2021-05-14

Report date

2021-06-30

Termination date

2022-08-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buena, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0636-2021