Class II · Moderate risk
Milrinone Lactate in 5% Dextrose Injection
Lack of assurance of sterility: customer complaints received for the presence of leaks.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Fluconazole Injection
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Class II · Moderate risk
Oxygen Refrigerated Liquid USP UN 1073
GMP Deviations: The firm does not include an SOP for testing for out of specifications.
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Blephamide
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Class II · Moderate risk
Buprenorphine HCI Injection
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
Class II · Moderate risk
Clozapine Tablets USP
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Amitriptyline HCL Tablets
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Estradiol 6 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 10 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 12.5 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 15 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 18 mg pellet
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 20 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 22 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 25 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Shield and Protect Moisture Barrier Cream
GMP Deviations; product may not meet cGMP requirements
Class II · Moderate risk
Vitamin D3 in Olive Oil Sdv 100
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Vitamin D3 in Olive Oil Sdv 100
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Vitamin B Complex 1ml Sdv Na Inj
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.