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Recall Observatory FDA recall evidence

Drug product

Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

D-0657-2022

August 06, 2020

Class II

Product summary

Firm
Family Pharmacy of Statesville
Event
Event 89773
Status
Terminated
Classification
Class II
Quantity
4 bags
Official record key
drug-enforcement:D-0657-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 07272020@2 BUD: 10/25/2020; 07302020@1 BUD: 10/28/2020; 08012020@1 BUD: 10/30/2020

Distribution pattern: NC only

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility