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Recall Observatory FDA recall evidence

Drug product

NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-815-25

D-0939-2018

June 12, 2018

Class II

Product summary

Firm
Avella of Deer Valley, Inc. Store 38
Event
Event 80307
Status
Terminated
Classification
Class II
Quantity
4,280 bags
Official record key
drug-enforcement:D-0939-2018

Official wording

Reason: Lack of Assurance of Sterility: Potential leakage of bags.

Code information: Lot #4/23/18 0101 81525P, 4/23/18 1020 81525P, BUD 6/22/2018;4/30/18 1123 81525P, 4/30/18 1311 81525P, BUD 6/29/2018; 5/1/18 3456 81525P, BUD 6/30/2018; 5/8/18 3213 81525P, BUD 7/7/2018.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility