The Recall Desk

FDA (Drugs) recall action 68683

Fougera Pharmaceuticals Inc. recalled 2 products on 2014-07-23

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-07-23
Critical
0
Units
114,982

Why these products were recalled

Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • LowFDA (Drugs)··2014-07-23

    Fougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns

    Fougera Pharmaceuticals is recalling specific lots of Triamcinolone Acetonide Lotion because the pH may not meet specifications at expiry.

    Product
    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.
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2014-07-23

    Fougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns

    Fougera Pharmaceuticals is recalling 3,594 bottles of Triamcinolone Acetonide Lotion because the pH may not meet specifications at expiry.

    Product
    Triamcinolone Acetonide Lotion USP, 0.025%, 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 0168-0336-60.
    Category
    Distribution
    0 states