October 12, 2018
Dr. Reddy's Laboratories Inc. is recalling 35,020 tubes of nystatin and triamcinolone acetonide cream, USP, 100,000 units/g and 1 mg/g, because tested samples failed to meet stability specifications for nystatin. The recall appeared in the October 10, 2018, US Food and Drug Administration (FDA) Enforcement Report
The recall affects three sizes of tubes, which were distributed throughout the United States:
- 15-g tubes (NDC 43598-431-44) from lots D06017 and D06018 (Exp. 9/18) and D06028 (Exp. 10/18);
- 30-g tubes (NDC 43598-431-30) from lots D06014, D06015, and D06016 (Exp. 9/18) and D06024, D06025, D06026, and D06027 (Exp. 10/18); and
- 60-g tubes (NDC 43598-431-60) from lots D06011, D06012, and D06013 (Exp. 9/18) and D06020, D06021, D06022, and D06023 (Exp. 10/18).
Dr. Reddy's Laboratories voluntarily initiated the recall September 21, 2018. On October 4, 2018, the FDA designated it Class II. Use of products under a Class II recall could cause temporary or medically reversible harm, or a remote possibility of serious harm.
Nystatin and triamcinolone acetonide cream is a prescription steroid-antifungal medication used to treat fungal infections of the skin, such as yeast infections.
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