Lidocaine HCL/ Sodium Bicarb recalled over sterility concerns
- Recall date
- September 23, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Guardian Pharmacy Services recalls Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
- Recall number
- D-0211-2017
- FDA classification
- Class I
- Brand / firm
- Guardian Pharmacy Services
- Sold / distributed
- Two medical facilities in TX
Why it was recalled
Non-Sterility: failed sterility test result.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
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