FDA recall D-0007-2019

Product

Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ - 08540 Rx Only Made in India

Reason for recall

Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2018-09-21

Report date

2018-10-10

Termination date

2023-02-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0007-2019