Reported Oct 10, 2018 · Terminated
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC…
Dr. Reddy's Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 15 g tube (NDC 43598-431-44) |
| 2 | 30 g tube (NDC 43598-431-30) |
| 3 | 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 |
- Lot codes and dates
Lot #: a) D06017D06018Exp 9/18D06028 Exp 10/18b) D06014D06015D06016Exp 9/18D06024D06025D06026D06027Exp 10/2018c) D06011D06012D06013Exp 9/18D06020D06021D06022D06023Exp 10/2018
- Amount recalled
- 35020 tubes
Where it was sold
- Nationwide
Why it was recalled
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
This product could cause temporary or reversible health problems — stop using it.
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