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Recall Observatory FDA recall evidence

Drug product

Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38

D-0131-2019

October 19, 2018

Class II

Product summary

Firm
Avella of Deer Valley, Inc. Store 38
Event
Event 81413
Status
Terminated
Classification
Class II
Quantity
1,360 bags
Official record key
drug-enforcement:D-0131-2019

Official wording

Reason: Lack of assurance of sterility

Code information: Lot # 7/10/18 0415 24110P, Exp 11/07/2018; 7/25/18 0247 24110P, Exp 11/22/2018

Distribution pattern: U.S.A. nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility