Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland…
Reason cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
365 FDA recalls mention Lidocaine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lidocaine.
Reason cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Reason cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Reason Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Reason CGMP Deviations:
Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the…
Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the…
Reason cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which…
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason Lack of Assurance of Sterility
Reason Lack of assurance of sterility.
Reason Lack of assurance of sterility.
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability…
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability…
Reason Failed viscosity specification - product was below specificcation
Reason cGMP Deviations
Reason cGMP deviations: Temperature abuse
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