Class II · Moderate risk Terminated
Trisodium Citrate 0.5% Solution
Reason CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
PF-Neostigmine Methylsulfate Injection
Reason CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk Terminated
Corsair Personal Care 99X Instant Foam Hand Sanitizer
Reason CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Class II · Moderate risk Terminated
Maxim Instant Foam Hand Sanitizer
Reason CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Class II · Moderate risk Terminated
Acetaminophen Injection
Reason Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
Class II · Moderate risk Terminated
Difluprednate Ophthalmic Emulsion 0.05%
Reason Lack of Assurance of Sterility: Complaints received of defective container closure.
Class II · Moderate risk Ongoing
PrednisoLONE Oral Solution USP
Reason Defective Container: Product has incomplete induction seals.
Class II · Moderate risk Terminated
Rifampin Capsules
Reason CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Class II · Moderate risk Terminated
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Divalproex Sodium Extended Release Tablets
Reason Failed dissolution specifications.
Class II · Moderate risk Terminated
fentaNYL Citrate in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg*…
Reason Discoloration
Class II · Moderate risk Terminated
Matzim LA
Reason Failed Dissolution Specifications: below specification limits for dissolution.
Class II · Moderate risk Terminated
Matzim LA
Reason Failed Dissolution Specifications: below specification limits for dissolution.
Class II · Moderate risk Ongoing
Luxury 70% Isopropyl Alcohol
Reason Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Class II · Moderate risk Ongoing
Luxury 70% Isopropyl Alcohol
Reason Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Class II · Moderate risk Terminated
Prednisone Tablets USP
Reason Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Class II · Moderate risk Terminated
Irbesartan Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Irbesartan Tablets
Reason Failed dissolution specifications.
Class II · Moderate risk Terminated
Magnesium Citrate SALINE LAXATIVE
Reason CGMP Deviations;
Class II · Moderate risk Terminated
Magnesium Citrate SALINE LAXATIVE
Reason CGMP Deviations
Class II · Moderate risk Terminated
Magnesium Citrate SALINE LAXATIVE
Reason CGMP Deviations
Class II · Moderate risk Terminated
Common Sense Fragrance Free Hand Sanitizer
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Protect U Guard Foaming Hand Sanitizer
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.