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.
Recall initiated: 20180921
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated