Drug recall
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC…
FDA recall event 81083 · Class II · Dr. Reddy's Laboratories, Inc.
Key facts
| Event ID | 81083 |
|---|---|
| Recall numbers | D-0007-2019 |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing. |
| Initiation date | Sep 21, 2018 |
| Report date | Oct 10, 2018 |
| Termination date | Feb 17, 2023 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3003989912 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: