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Recall Observatory FDA recall evidence

Drug product

Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8091-1, code 7128580911.

D-0753-2023

April 28, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92253
Status
Terminated
Classification
Class II
Quantity
1516 bags
Official record key
drug-enforcement:D-0753-2023

Official wording

Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Code information: Lot # 37-870983, Exp 06/10/2023; 37-879653, 37-879654, Exp 07/16/2023; 37-883186, Exp 07/29/2023; 37-888533, Exp 08/20/2023; 37-893416, Exp 09/09/2023

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility

Field note

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