FDA Drug Recalls

Recalls / Class II

Class IID-0057-2016

Product

ALPROSTADIL/PROCAINE, Injectable Solution, 40 MCG/0.1%/ML, 10 mL and 20 mL vials, 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
t01212015@26, t01292015@12, t02062015@28, t02092015@14, t02182015@37, t03112015@21, t03302015@3, t05182015@26, t06012015@9, t06042015@31, t06102015@29, t06222015@36, t07062015@4, t07312014@30, t08052014@19, t10082014@18, t10132014@8, t10142014@11, t10232014@23, t11072014@7, t11112014@24, t11182014@13, t12152014@15, and t12162014@7.

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
27 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-0057-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.