FDA-Drug2018-10-10Class II
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
Dr. Reddy's Laboratories, Inc.
Hazard
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Sold states
U.S.A. Nationwide
Affected count
35020 tubes
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0007-2019Don't want to check this manually?
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