Class II · Moderate risk
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Cephalexin for Oral Suspension
Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin
Class II · Moderate risk
Betadine (Povidone-Iodine)
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Class II · Moderate risk
Flurandrenolide Ointment USP
Failed Impurities/Degradation Specifications:
Class II · Moderate risk
Triple SupremeZen Plus 3500
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Class II · Moderate risk
PremierZen Black 5000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Class II · Moderate risk
PremierZen Extreme 3000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Class II · Moderate risk
Itraconazole Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Imperial Platinum 2000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
Burro en Primavera
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
PremierZen Extreme 3000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
Imperial Gold 2000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
Riomet (metformin hydrochloride oral solution)
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
Guanfacine Extended-Release Tablets 2 mg
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Class II · Moderate risk
Triple SupremeZen Gold 3500
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
PremierZen Platinum 5000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
Lite'n Foamy Healthcare Personnel Handwash
CGMP Deviations
Class II · Moderate risk
Lite'n Foamy Eucalyptus Mint Sanitizing Handwash
CGMP Deviations
Class II · Moderate risk
Lite'n Foamy E2 Sanitizing Handwash
CGMP Deviations
Class II · Moderate risk
Antiseptic Hand Cleaner
CGMP Deviations
Class II · Moderate risk
foamyiQ Lemon Blossom Hand Sanitizer
CGMP Deviations
Class II · Moderate risk
Thumbs Up 7 Red 70K
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Class II · Moderate risk
Cefprozil for Oral Suspension USP
Superpotent Drug
Class II · Moderate risk
Imperial Extreme 2000 Capsules
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class II · Moderate risk
PremierZen Black 5000 capsules
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.