FDA-Drug2019-07-03Class II

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.

Premier Pharmacy Labs Inc
Hazard

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.

Sold states
Nationwide in the USA
Affected count
323 vials
Manufactured in
8265 Commercial Way, N/A, Weeki Wachee, FL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1419-2019

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