FDA Drug Recalls

Recalls / Class II

Class IID-0056-2016

Product

ALPROSTADIL/PROCAINE, Injectable Solution, 20 MCG/0.1%/ML, 10 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
01122015@4, 02022015@2, 02102015@29, 02202015@14, 03302015@9, 04132015@7, 04222015@4, 05062015@6, 05132015@2, 05272015@11, 06032015@1, 06102015@6, 06222015@9, 06232014@2, 07082015@4, 07112014@22, 07292014@33, 08182014@8, 09022014@5, 09092014@27, 09172014@3, 10082014@3, 10272014@2, 11052014@2, 11262014@4, t03062015@44, t03242015@26, t06242015@8, t07182014@23, t11102014@21, and t12292014@19.

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
150 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-0056-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.