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
Reported: October 10, 2018 Initiated: September 21, 2018 #D-0007-2019
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.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 35020 tubes
- Distribution
- U.S.A. Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 35020 tubes.
Why was this product recalled? ▼
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 10, 2018. Severity: Moderate. Recall number: D-0007-2019.
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