Class I · High risk Terminated
Cubicin
Reason Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
Lidocaine HCl Injection
Reason 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 Terminated
Epel 18 mg Estradiol Pellet
Reason Non-Sterility: The recalled lot failed sterility testing.
Class I · High risk Terminated
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
Reason Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
Class I · High risk Terminated
Potassium Chloride Injection
Reason Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
Class I · High risk Terminated
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container
Reason Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Class I · High risk Terminated
0.9% Sodium Chloride Injection USP
Reason Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Class I · High risk Terminated
LACTATED RINGER'S and 5% DEXTROSE Injection USP
Reason Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
Class I · High risk Terminated
Oxcarbazepine Tablets
Reason 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 Terminated
Ibuprofen Tablets
Reason 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 Terminated
Ascorbic Acid 500 mg/mL Sterile Injection
Reason Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.
Class I · High risk Terminated
Marcaine
Reason 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 Terminated
Soliris
Reason Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
Class I · High risk Terminated
LOW Potassium Cardioplegia 792 mL
Reason Non Sterility; microbial contamination identified as Aspergillus species
Class I · High risk Terminated
adenosine 90 mg in 0.9% sodium chloride/90 mL
Reason Non Sterility; microbial contamination identified as Aspergillus species
Class I · High risk Terminated
del Nido Cardioplegia with Lidocaine 1052.8 ml
Reason Non Sterility; microbial contamination identified as Aspergillus species
Class I · High risk Terminated
Pediatric Cardioplegia
Reason Non Sterility; microbial contamination identified as Aspergillus species
Class I · High risk Terminated
Coumadin for Injection
Reason Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials
Class I · High risk Terminated
0.9 % Sodium Chloride Injection
Reason Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
Class I · High risk Terminated
African Black Ant
Reason Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Class I · High risk Terminated
Mojo Risen
Reason Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Class I · High risk Terminated
Black Ant
Reason Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Class I · High risk Terminated
Lite Fit USA
Reason Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Lite Fit USA, lot 13165, due to undeclared sibutramine, making it an unapproved new drug.
Class I · High risk Terminated
Atropine Sulfate 0.4 mg/ml Injection
Reason Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk Terminated
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag
Reason Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.