Class I · High risk
Ascorbic Acid 500 mg/mL Sterile Injection
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
FDA Drug Recalls
1,463 recalls · Class I, newest first
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
Class I · High risk
Dianeal Low Calcium
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
Class I · High risk
Lidocaine HCl Injection
Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
Class I · High risk
Epel 18 mg Estradiol Pellet
Non-Sterility: The recalled lot failed sterility testing.
Class I · High risk
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
Class I · High risk
Potassium Chloride Injection
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
Class I · High risk
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Class I · High risk
LACTATED RINGER'S and 5% DEXTROSE Injection USP
Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
Class I · High risk
Oxcarbazepine Tablets
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.
Class I · High risk
Ibuprofen Tablets
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544
Class I · High risk
Ascorbic Acid 500 mg/mL Sterile Injection
Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.
Class I · High risk
Marcaine (bupivacaine HCl)
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Class I · High risk
Soliris (eculizumab)
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Class I · High risk
LOW Potassium Cardioplegia 792 mL
Non Sterility; microbial contamination identified as Aspergillus species
Class I · High risk
adenosine 90 mg in 0.9% sodium chloride/90 mL
Non Sterility; microbial contamination identified as Aspergillus species
Class I · High risk
del Nido Cardioplegia with Lidocaine 1052.8 ml
Non Sterility; microbial contamination identified as Aspergillus species
Class I · High risk
Pediatric Cardioplegia
Non Sterility; microbial contamination identified as Aspergillus species
Class I · High risk
Coumadin for Injection
Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials
Class I · High risk
0.9 % Sodium Chloride Injection
Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
Class I · High risk
African Black Ant
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Class I · High risk
Mojo Risen
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Class I · High risk
Black Ant
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.