FDA Drug Recalls

Recalls / Class II

Class IID-0067-2016

Product

CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 175 UNITS/0.175ML per syringe, packaged in 14, 26, and 40-count containers, 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
01052015@18, 01072015@12, 01122015@13, 01142015@7, 01192015@18, 01212015@16, 01262015@11, 02022015@13, 02192015@10, 02232015@22, 03042015@20, 03092015@46, 03162015@13, 03182015@17, 03252015@23, 03302015@13, 04012015@11, 04152015@14, 04212015@15, 04272015@13, 05062015@19, 05112015@27, 05202015@16, 05272015@29, 06032015@19, 06102015@27, 06152015@31, 06172015@40, 06222015@27, 06292015@27, 07012015@12, 07062015@16, 07092014@4, 07152015@13, 07162014@3, 07212014@4, 07232014@15, 07282014@14, 07302014@5, 08112014@19, 08182014@7, 08252014@14, 09022014@22, 09152014@10, 09172014@16, 09222014@6, 09292014@22, 10062014@15, 10132014@20, 10222014@14, 10272014@13, 11032014@17, 11052014@19, 11262014@13, 12302014@8, t03022015@10, t04072015@32, t05112015@26, t05152015@4, t07132015@6.

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
1 (14-count) container, 1(40-count) container, 30 (26-count) container
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-0067-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.