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
Reported: July 31, 2019 Initiated: July 17, 2019 #D-1518-2019
Product Description
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
Reason for Recall
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 33,939 tubes
- Distribution
- Nationwide within the United States
- Location
- Baltimore, MD
Frequently Asked Questions
What product 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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 33,939 tubes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 31, 2019. Severity: Low. Recall number: D-1518-2019.
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