Class II · Moderate risk Terminated
ePHEDrine 50mg
Reason Lack of Assurance of Sterility: Potential leakage of bags.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
0.2% ROPivacaine - OnQ Pump
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
Monsel's Solution
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Irinotecan Hydrochloride Injection
Reason Superpotent Drug: High out of specification assay value results for potency.
Class II · Moderate risk Terminated
Irinotecan Hydrochloride Injection
Reason Superpotent Drug: High out of specification assay value results for potency.
Class II · Moderate risk Terminated
Kit for the Preparation of Technetium Tc99m Medronate
Reason Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Class II · Moderate risk Terminated
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride
Reason Superpotent and Subpotent
Class II · Moderate risk Terminated
5% Dextrose Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
0.45% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
Fluticasone propionate Nasal Spray
Reason Presence of foreign substance: glass particles
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason 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 Terminated
Acne Shave 3 Step Shaving System
Reason CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk Terminated
Acne Shave
Reason CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk Terminated
Acne Shave Post-Shave Moisturizer
Reason CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk Terminated
X-Jow
Reason CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk Terminated
READYFLUSH PROTECT with Dimethicone
Reason Microbial Contamination of a Non-Sterile Product.
Class II · Moderate risk Terminated
Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes…
Reason Lack of sterility assurance.