FDA recall D-0599-2024

Product

Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60

Reason for recall

Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-06-24

Report date

2024-07-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0599-2024