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Pyridoxine HCL (Medaus) – Sterility Concern (2013)

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Class IIModerate

FDAAug 23, 2013Nationwide• Medaus, Inc.

Dexpanthenol Vial (Wellness Pharmacy) – Sterility Concern (2013)

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.

Class IIModerate

FDA

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Pyridoxine HCL (Medaus) – Sterility Concern (2013)

Dexpanthenol Vial (Wellness Pharmacy) – Sterility Concern (2013)

Acetylcysteine Solution (JCB Labs) – Sterility Concern (2013)

L-Glutathione Solution (Medaus) – Sterility Concern (2013)

Magnesium Sulfate (Wellness) – Microbial Contamination (2013)

Methyl B12 Vial (Wellness Pharmacy) – Sterility Concern (2013)

Sodium Citrate with Gentamicin (JCB Labs) – Sterility Concern (2013)

Sodium Citrate Solution (JCB Labs) – Sterility Concern (2013)

Epinephrine Solution (JCB Labs) – Sterility Concern (2013)

Tea Kettle (Chefmate) – burn hazard (2013)

SuperPan Tu Pan Natural (Lucy's Kitchen) – Undeclared Wheat (2013)

Junior Beds (IKEA) – Laceration Risk (2013)

Children's Sandals (JP Boden) – Fall Risk (2013)

Compact Utility Tractors (John Deere) – Serious Injury Risk (2013)

Wind Speed Sensors (LSI) – Impact Injury (2013)

Uppercut Knife (Gerber) – Laceration Hazard (2013)

Kensington Court Heels (JP Boden) – fall hazard (2013)

Lennox Gas Fireplaces (Lennox) – Gas leak risk (2013)

Johnny G. Krankcycle (Matrix) – Fall hazard (2013)

Flour Tortillas (Tortilleria Lupita) – Undeclared soy (2013)