Class II · Moderate risk
fentaNYL (10 mcg per mL)
Lack of Assurance of Sterility: Potential leakage of bags.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
EPINEPHrine
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
EPINEPHrine
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
ePHEDrine 50mg
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
0.2% ROPivacaine - OnQ Pump
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
Monsel's Solution
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Superpotent Drug: High out of specification assay value results for potency.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Superpotent Drug: High out of specification assay value results for potency.
Class II · Moderate risk
Kit for the Preparation of Technetium Tc99m Medronate
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Class II · Moderate risk
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride
Superpotent and Subpotent
Class II · Moderate risk
5% Dextrose Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
0.45% Sodium Chloride Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
Fluticasone propionate Nasal Spray
Presence of foreign substance: glass particles
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
Class II · Moderate risk
Acne Shave 3 Step Shaving System
CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk
Acne Shave
CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk
Acne Shave Post-Shave Moisturizer
CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk
X-Jow (menthol USP)
CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk
READYFLUSH PROTECT with Dimethicone
Microbial Contamination of a Non-Sterile Product.
Class II · Moderate risk
Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials…
Lack of sterility assurance.
Class II · Moderate risk
MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial…
Lack of sterility assurance.