Recalls / Class II
Class IID-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
- Affected lot / code info
- 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
Why it was recalled
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 35020 tubes
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2018-09-21
- FDA classified
- 2018-10-04
- Posted by FDA
- 2018-10-10
- Terminated
- 2023-02-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0007-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.