The Recall Desk

FDA (Drugs) recall action 81867

Syntho Pharmaceuticals, Inc. recalled 2 products on 2019-01-23

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
2019-01-23
Critical
0
Units
10,000

Why these products were recalled

CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.

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

  • ModerateFDA (Drugs)··2019-01-23

    Syntho Pharmaceuticals Recalls EEMT HS Tablets Due to Sub-Potency

    Syntho Pharmaceuticals is recalling 5,000 bottles of EEMT HS tablets due to sub-potency and cGMP violations. The product was distributed nationwide.

    Product
    EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-01-23

    Syntho Recalls EEMT Tablets Due to Sub-Potency and cGMP Violations

    Syntho Pharmaceuticals is recalling 5,000 bottles of EEMT tablets because they were found to be sub-potent and involved cGMP violations.

    Product
    EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-010-01
    Category
    Distribution
    0 states