FDAFDA · Food and drugs·Recall number D-1419-2019
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.
Published July 3, 2019 · Recall initiated: June 18, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Premier Pharmacy Labs Inc
- Distributor
- Nationwide in the USA
- Lot
- All lots remaining within expiry.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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