D-0007-2019 Class II Terminated
FDA drug recall D-0007-2019 was initiated by Dr. Reddy's Laboratories, Inc. on Sep 21, 2018 and is designated Class II. Reason for recall: Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing. The recall status is terminated (terminated Feb 17, 2023). Affected quantity: 35020 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 10, 2018
- Initiation Date
- Sep 21, 2018
- Termination Date
- Feb 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35020 tubes
Product Description
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.
Distribution Pattern
U.S.A. Nationwide
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0007-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026