Recalls / Class III
Class IIID-0426-2017
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
- Affected lot / code info
- Lot: 09122016:34, exp 09/07/2017
Why it was 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
Recalling firm
- Firm
- Pharm D Solutions, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1304 S Loop W, Houston, Texas 77054-4010
Distribution
- Quantity
- 4 mL: 510 vials, 5 mL: 486 vials
- Distribution pattern
- AZ and WA
Timeline
- Recall initiated
- 2016-10-12
- FDA classified
- 2017-01-09
- Posted by FDA
- 2017-01-18
- Terminated
- 2017-05-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0426-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.