FDA Drug Recalls

Recalls / Class II

Class IID-0046-2016

Product

Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Affected lot / code info
Lot #: 09082015@12, Exp10/23/2015; 09032015@16, Exp 10/18/2015

Why it was recalled

Lack of assurance of sterility

Recalling firm

Firm
Bedford Pharmacy
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
209 Route 101, N/A, Bedford, New Hampshire 03110-5440

Distribution

Quantity
3 vials
Distribution pattern
NH, MA

Timeline

Recall initiated
2015-09-22
FDA classified
2015-10-15
Posted by FDA
2015-10-21
Terminated
2016-06-08
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0046-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.