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
Reported: January 18, 2017 Initiated: October 12, 2016 #D-0426-2017
Product Description
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
Reason for Recall
Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct
Details
- Recalling Firm
- Pharm D Solutions, LLC
- Units Affected
- 4 mL: 510 vials, 5 mL: 486 vials
- Distribution
- AZ and WA
- Location
- Houston, TX
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Pharm D Solutions, LLC. Units affected: 4 mL: 510 vials, 5 mL: 486 vials.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 18, 2017. Severity: Low. Recall number: D-0426-2017.
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