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Recall Observatory FDA recall evidence

Drug product

2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1026-2019

March 13, 2019

Class II

Product summary

Firm
Advanced Pharma Inc.
Event
Event 82398
Status
Terminated
Classification
Class II
Quantity
1540 syringes
Official record key
drug-enforcement:D-1026-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: 10/18/18 2217 01122S Exp. 3/17/2019

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility