Recalls / Class II
Class IID-1338-2019
Product
Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-10
- Affected lot / code info
- Lot #: a) 10242018:70/P, Exp. 08/31/2019; b) 10242018:70/A Exp. 08/31/2019; 02262019:49/A Exp. 11/30/2019
Why it was recalled
Lack of Sterility Assurance.
Recalling firm
- Firm
- Pharm D Solutions, LLC
- Notification channel
- Press Release
- Type
- FDA Mandated
- Address
- 1304 S Loop W, N/A, Houston, Texas 77054-4010
Distribution
- Quantity
- a) 114 vials and b) 566 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-05-23
- FDA classified
- 2019-06-07
- Posted by FDA
- 2019-06-19
- Terminated
- 2021-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1338-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.