Class II · Moderate risk
NaturalCare bioAllers
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
FDA Drug Recalls
316 recalls, newest first
Class III · Low risk
Evamist (estradiol transdermal spray)
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Class II · Moderate risk
Purely Soothing MSM Nasal Spray
CGMP Deviations
Class I · High risk
Purely Soothing 15% MSM Drops
Non-Sterility
Class I · High risk
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand…
Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Class II · Moderate risk
Fentanyl 500mcg
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Class II · Moderate risk
Tacrolimus Capsules
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 capsules.
Class II · Moderate risk
Delsam Pharma's ARTIFICIAL TEARS
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 same conditions as the lots found to be contaminated.
Class I · High risk
Delsam Pharma's ARTIFICIAL TEARS
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class II · Moderate risk
Artificial Tears
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 same conditions as the lots found to be contaminated.
Class I · High risk
Artificial Tears
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class III · Low risk
Atropine Sulfate Ophthalmic Solution
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
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
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