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Recall Observatory FDA recall evidence

Drug product

ALPROSTADIL/PROCAINE, Injectable Solution, 40 MCG/0.1%/ML, 10 mL and 20 mL vials, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0057-2016

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
27 vials
Official record key
drug-enforcement:D-0057-2016

Official wording

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

Code information: t01212015@26, t01292015@12, t02062015@28, t02092015@14, t02182015@37, t03112015@21, t03302015@3, t05182015@26, t06012015@9, t06042015@31, t06102015@29, t06222015@36, t07062015@4, t07312014@30, t08052014@19, t10082014@18, t10132014@8, t10142014@11, t10232014@23, t11072014@7, t11112014@24, t11182014@13, t12152014@15, and t12162014@7.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility