Reported Jan 18, 2017 · Terminated
Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop…
Pharm D Solutions, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pharm D Solutions, LLC · 1304 S Loop W · Houston, TX · 77054-4010
Is this the product you have?
- 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 codes and dates
- Lot
09122016:34exp 09/07/2017
- Lot
- Amount recalled
- 4 mL: 510 vials, 5 mL: 486 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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