Lidocaine-phenylephrine 1%-1 recalled over sterility concerns
- Recall date
- October 2, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Pine Pharmaceuticals, LLC recalls Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway…
- Recall number
- D-0059-2024
- FDA classification
- Class II
- Brand / firm
- Pine Pharmaceuticals, LLC
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
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