Class II · Moderate risk
Nafcillin various strengths in sterile water for injection bags
Lack of sterility assurance.
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.
14,535 recalls, newest first.
Class II · Moderate risk
Meropenem various strengths in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Cefuroxime various strengths in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin various strengths in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Piperacillin/ tazobactam various strength in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Ertapenem various strength in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Imipenem/ cilastatin various strength in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Ceftazidime various strength in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Cefoxitin various strength in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Cefepime various strengths in normal saline
Lack of sterility assurance.
Class II · Moderate risk
Aztreonam 1 gram in normal saline
Lack of sterility assurance.
Class II · Moderate risk
Amikacin various strength in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Liposomal Amphotericin B 130 mg in dextrose bags
Lack of sterility assurance.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Class II · Moderate risk
Fluconazole Injection
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Class II · Moderate risk
Benzonatate Capsules
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.
Class II · Moderate risk
B-Lipo
Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss
Class II · Moderate risk
Entertainer's Secret Throat Relief
Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli
Class II · Moderate risk
Alprazolam tablets
Subpotent Drug
Class II · Moderate risk
J-TAN D PD Drops
Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
Class II · Moderate risk
Gabapentin Capsules
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Class II · Moderate risk
Gabapentin Capsules
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Class II · Moderate risk
Gabapentin Capsules
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Class II · Moderate risk
Hydroxocobalamin Injection Solution 1 mg/mL Inj.
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product