Class II · Moderate risk
Ohm Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
FDA Drug Recalls
207 recalls, newest first
Class II · Moderate risk
Hand Sanitizer
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.
Class II · Moderate risk
Hand Sanitizer
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.
Class II · Moderate risk
Sterile Water for Injection
CGMP Deviations: potential for trace amounts of product carryover.
Class II · Moderate risk
0.9% Sodium Chloride Injection
CGMP Deviations: potential for trace amounts of product carryover.
Class II · Moderate risk
Humatrix Microclysmic Gel
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Class II · Moderate risk
Techni-Care Chloroxylenold 3%
CGMP Deviations: initiated due to violations of CGMP manufacturing practices