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Recall Observatory FDA recall evidence

Drug product

Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-176-31, barcode 6 69623 17631 0.

D-1419-2019

June 18, 2019

Class II

Product summary

Firm
Premier Pharmacy Labs Inc
Event
Event 83146
Status
Terminated
Classification
Class II
Quantity
323 vials
Official record key
drug-enforcement:D-1419-2019

Official wording

Reason: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Code information: All lots remaining within expiry.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility