Dr. Reddy's Laboratories, Inc. recalls Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44)
Recalled October 10, 2018 · FDA recall D-0007-2019 · Dr. Reddy's Laboratories
Hazard
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing. · FDA Class II
Units
35020 tubes
Sold at
U.S.A. Nationwide
Description
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
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
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →