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Recall Observatory FDA recall evidence

Drug product

TESTOSTERONE CYPIONATE (COMPOUNDED), Injectable Solution, 200 MG/ML, syringe sizes: 5mL and 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0141-2016

July 24, 2015

Class II

Product summary

Firm
JD & SN Inc., dba Moses Lake Professional Pharmacy
Event
Event 71806
Status
Terminated
Classification
Class II
Quantity
38 (10mL) syringes, 7 (5mL) syringes
Official record key
drug-enforcement:D-0141-2016

Official wording

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

Code information: t12232014@27, t11112014@12, t08072014@38, t07142015@22, t07102015@26, t06232014@25, t06042015@24, 06172015@13, 04202015@7, 03092015@11, 02022015@3, 01192015@8, 01052015@10.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility