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Recall Observatory FDA recall evidence

Drug 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

D-0143-2016

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
243 (10mL) syringes, 5 (5mL) syringes
Official record key
drug-enforcement:D-0143-2016

Official wording

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

Code information: 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.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility