FDA Drug Recalls

Recalls / Class II

Class IID-0143-2016

Product

TESTOSTERONE CYPIONATE FOR SUBQ INJECTION, Injectable Solution, 200 mg/mL, syringe size: 5ml and 10mL, 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
t12312014@11, t10302014@9, t08062014@28, t05292015@30, t04282015@12, t04092015@22, t03302015@1, t03102015@29, t02172015@2, t01292015@18, 12082014@10, 11242014@5, 11122014@5, 10222014@24, 10012014@19, 09242014@7, 09152014@17, 08152014@27, 08042014@6, 07112014@23, 07082015@8, 06172015@14, 05272015@12, 05132015@12, 04082015@1, 03092015@11, 02232015@2.

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
243 (10mL) syringes, 5 (5mL) syringes
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-0143-2016. 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