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Recall Observatory FDA recall evidence

Drug product

VITAMIN D3 OIL, Injectable Solution, 50,000 UNITS/ML, syringe sizes: 10 mL and 30 mL, Rx only,JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0155-2016

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
6 (30mL syringe), 2 (10mL syringe)
Official record key
drug-enforcement:D-0155-2016

Official wording

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

Code information: t10242014@16, t05282015@21, t03182015@35.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility