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Recall Observatory FDA recall evidence

Drug product

METHYLCOBALAMIN, injectable Solution, 10 MG/ML, syringe sizes: 10mL; 22.5mL; and 30mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0103-2016

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
2 (10mL) syringes, 1 (30mL) syringe, 1 (22.5mL) syringe
Official record key
drug-enforcement:D-0103-2016

Official wording

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

Code information: t08062014@8, t05152015@25, t01192015@26, t01072015@7.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility