Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets USP
Reason CGMP Deviations
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Zanilast+ Gel Antiseptic Hand Sanitizer
Reason GMP Deviations: Potential to contain 1-propanol.
Class II · Moderate risk Terminated
Zanilast+ Gel Antiseptic Hand Sanitizer
Reason GMP Deviations: Potential to contain 1-propanol.
Class II · Moderate risk Terminated
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
Reason cGMP Deviations
Class II · Moderate risk Terminated
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
Reason cGMP Deviations
Class I · High risk Terminated
Goldenseal Root Powder Organic
Reason Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others.
Class I · High risk Terminated
Tranexamic Acid Injection
Reason Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Class I · High risk Terminated
Amiodarone Hydrochloride Injection
Reason Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Class I · High risk Terminated
Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing…
Reason Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk Terminated
Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC
Reason Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk Terminated
SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump
Reason Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk Terminated
SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump
Reason Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class II · Moderate risk Terminated
Buprenorphine HCl Injection
Reason Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Class II · Moderate risk Terminated
Florance Morris ANTISEPTIC Hand Sanitizer
Reason CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class I · High risk Terminated
Florance Morris ANTISEPTIC Hand Sanitizer
Reason Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
Class I · High risk Terminated
Volu-Sol Handrub Sanitizing Solution
Reason Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Class II · Moderate risk Terminated
BusPIRone Hydrochloride Tablets
Reason Failed Impurity /Degradation Specifications
Class II · Moderate risk Terminated
Sulfamethoxazole and Trimethoprim Tablets
Reason Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Class II · Moderate risk Terminated
Prednisone Tablets
Reason Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
Class II · Moderate risk Ongoing
Elitek
Reason Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
Class II · Moderate risk Terminated
Just Hand Sanitizer
Reason Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk Terminated
Always Be Clean Hand Sanitizer
Reason Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk Terminated
UltraCruz Hand Sanitizing Gel Antimicrobial
Reason Subpotent drug
Class I · High risk Terminated
Incredible Products Gelbac T Antibacterial Hand Gel
Reason Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP
Reason Failed Tablet/Capsule Specification; complaint of bulging tablet