Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.
Reported: March 19, 2014 Initiated: January 29, 2014 #D-1152-2014
Product Description
Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.
Reason for Recall
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Details
- Recalling Firm
- Fougera Pharmaceuticals Inc.
- Units Affected
- 493,192 tubes
- Distribution
- Nationwide.
- Location
- Melville, NY
Frequently Asked Questions
What product was recalled? ▼
Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.. Recalled by Fougera Pharmaceuticals Inc.. Units affected: 493,192 tubes.
Why was this product recalled? ▼
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 19, 2014. Severity: Low. Recall number: D-1152-2014.
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