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Recall Observatory FDA recall evidence

Drug product

Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0097-30

D-0930-2022

May 09, 2022

Class II

Product summary

Firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Event
Event 90204
Status
Completed
Classification
Class II
Quantity
1195 vials
Official record key
drug-enforcement:D-0930-2022

Official wording

Reason: Lack of assurance of sterility.

Code information: Lots: L246022 BUD: 6/22/2022; B24208-22 BUD: 8/8/2022

Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility