Class II · Moderate risk
0.9% Sodium Chloride Injection
CGMP Deviations: potential for trace amounts of product carryover.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Allopurinol Tablets USP
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Class II · Moderate risk
Rocuronium Bromide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specification
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specification
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specification
Class III · Low risk
Levofloxacin Tablets
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Class III · Low risk
SINUVA (mometasone furoate)
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
BiMix STD 001
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Plus 002
Lack of Assurance of Sterility
Class II · Moderate risk
BiMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin Injection Solution
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Plus 001
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Prostaglandin
Lack of Assurance of Sterility
Class II · Moderate risk
Prostaglandin
Lack of Assurance of Sterility