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Recall Observatory FDA recall evidence

Drug product

Chorionic Gonadotropin 2,000U/mL PF Injection, 8 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252

D-1483-2019

June 26, 2019

Class II

Product summary

Firm
First Pharma Associates LLC dba Riverpoint Pharmacy
Event
Event 83253
Status
Terminated
Classification
Class II
Quantity
8 mL
Official record key
drug-enforcement:D-1483-2019

Official wording

Reason: Lack of Assurance of Sterility.

Code information: Lot #: 06212019@15, Exp. 07/24/2019

Distribution pattern: ID, WA only

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility