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

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

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

  • 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
  • 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