FDAFDA · Food and drugs·Recall number D-0007-2019
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
Published October 10, 2018 · Recall initiated: September 21, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- U.S.A. Nationwide
- Lot
- Lot #: a) D06017, D06018, Exp 9/18; D06028 Exp 10/18; b) D06014, D06015, D06016, Exp 9/18; D06024, D06025, D06026, D06027, Exp 10/2018; c) D06011, D06012, D06013, Exp 9/18; D06020, D06021, D06022, D06023, Exp 10/2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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