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Recall Observatory FDA recall evidence

Drug product

CHORIONIC GONADOTROPIN, Injectable Solution,175 UNITS/1.5mg per syringe with Methylcobalamin, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0063-2016

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
834 syringes
Official record key
drug-enforcement:D-0063-2016

Official wording

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

Code information: 04292015@12, 05042015@8, 05202015@21, 06102015@25, 06242015@14, 07012015@8, 07062015@21, t03062015@15, t03122015@33, t03182015@45, t03192015@2, t04082015@14, t04082015@3, t04202015@22, t05082015@27, t05192015@29, t06022015@37, and t07152015@5.

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility