Pharm D Solutions, LLC: 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

Agency Publication Date: January 9, 2017

Affected Products

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

Lot: 09122016:34, exp 09/07/2017

Lot Numbers:

09122016

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

Lots: 07272016:03 Expiration Date: 01/23/2017 and 09142016:88 Expiration Date: 03/07/2017

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75552

Status: Resolved

Manufacturer: Pharm D Solutions, LLC

Manufactured In: United States

Units Affected: 2 products (4 mL: 510 vials, 5 mL: 486 vials; 112 bottles)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

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