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Signs of contamination or degradation: Cloudiness or turbidity (potential bacterial growth or precipitation) Visible particles or crystals (potential contamination or degradation products) Discolouration or browning (potential oxidative degradation) Visible mould growth (rare, but indicates severe contamination) Unpleasant or unusual odour (potential bacterial contamination) Action: If any of these signs are observed, discard the vial immediately

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Retrieved 7 January 2024

For anyone following the compounding debate, this letter is Exhibit A for why the FDAs concerns about quality in the compounding space are not abstract