Lupin Pharmaceuticals Inc. recalls Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharma…
- Recall date
- July 17, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1518-2019
- FDA classification
- Class III
- Brand / firm
- Lupin Pharmaceuticals Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01
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