Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.
Reported: July 23, 2014 Initiated: July 3, 2014 #D-1440-2014
Product Description
Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.
Reason for Recall
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Details
- Recalling Firm
- Fougera Pharmaceuticals Inc.
- Units Affected
- 111,388 Bottles
- Distribution
- Nationwide
- Location
- Melville, NY
Frequently Asked Questions
What product was recalled? ▼
Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.. Recalled by Fougera Pharmaceuticals Inc.. Units affected: 111,388 Bottles.
Why was this product recalled? ▼
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 23, 2014. Severity: Low. Recall number: D-1440-2014.
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