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Recall Observatory FDA recall evidence

Drug product

PAPAVERINE/PHENTOLAMINE, Injectable Solution, 30MG/1MG/ML, 10 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314

D-0111-2016

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
8 syringes
Official record key
drug-enforcement:D-0111-2016

Official wording

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

Code information: t09172014@29, t08252014@1, t06082015@10, t03032015@26, t02272015@23, t01232015@12, t01122015@36, t05132015@15

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility