FDA Drug Recalls

Recalls / Class II

Class IID-0062-2016

Product

CHORIONIC GONADOTROPIN, Injectable Solution, 1000 UNITS/0.1 mL, 1 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

Affected lot / code info
t12172014@5, t12162014@23, t09102014@8, t05272015@14, t05222015@20, t03202015@23, t03062015@32, and t02122015@14.

Why it was recalled

Lack of Assurance of Sterility; all sterile human compounded drugs within expiry

Recalling firm

Firm
JD & SN Inc., dba Moses Lake Professional Pharmacy
Notification channel
Press Release
Type
Voluntary: Firm initiated
Address
1555 Pilgrim St, N/A, Moses Lake, Washington 98837-4623

Distribution

Quantity
95 vials
Distribution pattern
Nationwide

Timeline

Recall initiated
2015-07-24
FDA classified
2015-10-27
Posted by FDA
2015-11-04
Terminated
2016-04-13
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0062-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls