316 recalls, newest first
Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Reason Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the…
Reason CGMP Deviations
Reason Non-Sterility
Reason Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Reason Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Reason Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg…
Reason CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the…
Reason Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Reason CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the…
Reason Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Reason Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Reason CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer…
Reason CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer…
Reason CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Reason CGMP Deviations: initiated due to violations of CGMP manufacturing practices