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Recall Observatory FDA recall evidence

Drug product

Hydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252

D-1476-2019

June 26, 2019

Class II

Product summary

Firm
First Pharma Associates LLC dba Riverpoint Pharmacy
Event
Event 83253
Status
Terminated
Classification
Class II
Quantity
60 mL
Official record key
drug-enforcement:D-1476-2019

Official wording

Reason: Lack of Assurance of Sterility.

Code information: Lot #: 05282019@53, Exp. 08/26/2019 and Exp. 08/28/2019

Distribution pattern: ID, WA only

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility