Class II · Moderate risk
Walgreens Lubricant Eye Drops
Lack of Assurance of Sterility
FDA Drug Recalls
560 recalls, newest first
Class II · Moderate risk
Walgreens Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Reliable -1 Laboratories
Lack of Assurance of Sterility
Class II · Moderate risk
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Lack of Assurance of Sterility
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Class III · Low risk
Buprenorphine Sublingual Tablets
Labeling: Label Mix-up
Class III · Low risk
Revcovi (elapegademase-lvlr)
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Class II · Moderate risk
2% Chlorhexidine Gluconate* Cloth
Cross Contamination with Other Products
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Class II · Moderate risk
The One Spf 50 Invisible Sunscreen Gel
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Class II · Moderate risk
The One Spf 50 Invisible Sunscreen Gel
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Class II · Moderate risk
The One Spf 50 Invisible Sunscreen Gel
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Class II · Moderate risk
The One Spf 50 Invisible Sunscreen Gel
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Paxil CR
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Class I · High risk
Lactated Ringer's Injection USP
Presence of Particulate matter.
Class I · High risk
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Class I · High risk
Tyenne (tocilizumab-aazg)
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.