Class II · Moderate risk
Cephalexin for Oral Suspension
Sub-Potent Drug: Out of specification test results for potency (below specification).
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Cephalexin for Oral Suspension
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Class II · Moderate risk
Cephalexin for Oral Suspension
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Class II · Moderate risk
Strides Pharma Inc.Potassium Chloride Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets USP
CGMP Deviations
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets USP
CGMP Deviations
Class II · Moderate risk
Zanilast+ Gel Antiseptic Hand Sanitizer
GMP Deviations: Potential to contain 1-propanol.
Class II · Moderate risk
Zanilast+ Gel Antiseptic Hand Sanitizer
GMP Deviations: Potential to contain 1-propanol.
Class II · Moderate risk
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
cGMP Deviations
Class II · Moderate risk
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
cGMP Deviations
Class I · High risk
Goldenseal Root Powder Organic
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
Tranexamic Acid Injection
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
Amiodarone Hydrochloride Injection
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
Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing…
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk
Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk
SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class I · High risk
SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class II · Moderate risk
Buprenorphine HCl Injection
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
Class II · Moderate risk
Florance Morris ANTISEPTIC Hand Sanitizer
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
Florance Morris ANTISEPTIC Hand Sanitizer
Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
Class I · High risk
Volu-Sol Handrub Sanitizing Solution
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets
Failed Impurity /Degradation Specifications
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
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
Prednisone Tablets
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
Elitek (rasburicase)
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.