2,357 recalls · Class II, newest first
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Failed Impurities/Degradation Specifications
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
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