The Recall Desk

FDA (Drugs) recall action 75552

Pharm D Solutions, LLC recalled 2 products on 2017-01-18

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
2017-01-18
Critical
0
Units
112

Why these products were recalled

Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct

Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct

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.

States named across these recalls

1–2 of 2

  • LowFDA (Drugs)··2017-01-18

    Testosterone Cypionate Injection Recalled for Incorrect Excipient Labeling

    Pharm D Solutions is recalling Testosterone Cypionate 200 mg/mL vials because the label incorrectly lists grapeseed oil instead of sesame oil.

    Product
    Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2017-01-18

    Pharm D Solutions Recalls HCG-Vitamin B12 Injection Due to Labeling Error

    Pharm D Solutions is recalling 112 vials of HCG-Vitamin B12 injection because the product description incorrectly states the HCG strength as 7500 units instead of 5000 units.

    Product
    HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-20
    Category
    Distribution
    2 states