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Bacteriostatic Water Pre-blend uses 2.5 mL per 15 mg vial

In June and December of 2024, several 503B registered facilities that have never been inspected by the FDA filed biannual reports listing their compounded products: Bennett Pharmaceuticals of America, LLC: June and December 2024 filings (see appendices) reported that the company created tetracaine hydrochloride, bupivacaine hydrochloride, and phenylephrine hydrochloride in spray bottles, jars, and glass bottleslikely for topical dental anesthetic

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Second, and more critically, the expansion of water as it freezes can create immense pressure inside the vial, potentially causing micro-fractures in the glass or compromising the seal of the rubber stopper