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Leiter's Compounding

Leiter's Compounding Recalls

All product recalls associated with Leiter's Compounding.

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Recall Summary

Total Recalls

9

Past Year

0

Class I (Serious)

0

Most Recent

Sep 2016

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–9 of 9 recalls

Cyclopentolate HCl 1% - Tropicamide 1% (Leiter's) – sterility risk (2016)

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Class IIModerate

FDASep 20, 2016Nationwide• Leiter's Compounding

Mitomycin 0.02% Injection (Leiter's Compounding) – Sterility Concern (2016)

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Class IIModerate

FDASep 20, 2016Nationwide• Leiter's Compounding

Brilliant Blue G Injection (Leiter's) – sterility risk (2016)

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Moderate

FDASep 20, 2016Nationwide• Leiter's Compounding

Moxifloxacin Sterile Solution (Leiter's) – sterility risk (2016)

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Class IIModerate

FDASep 20, 2016Nationwide• Leiter's Compounding

Cefuroxime Sodium Injection (Leiter's) – sterility risk (2016)

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Class IIModerate

FDASep 20, 2016Nationwide• Leiter's Compounding

Lidocaine HCl Injection (Leiter's) – sterility risk (2016)

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Class IIModerate

FDASep 20, 2016Nationwide• Leiter's Compounding

Vancomycin Injection (Leiter's) – sterility risk (2016)

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Class IIModerate

FDASep 20, 2016Nationwide• Leiter's Compounding

Prednisolone Acetate Placebo (Leiter's) – sterility risk (2016)

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Class IIModerate

FDASep 20, 2016Nationwide• Leiter's Compounding

Atropine Sulfate Solution (Leiter's) – sterility risk (2016)

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Class IIModerate

FDASep 20, 2016Nationwide• Leiter's Compounding