Class II · Moderate risk
Copaxone (glatiramer acetate injection)
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Metoprolol Tartrate Tablets USP 50 mg
Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)
Class II · Moderate risk
Zemplar (paricalcitol)
CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
Class II · Moderate risk
Dent's Extra Strength Toothache Gum
Superpotent; benzocaine
Class II · Moderate risk
Estradiol Hemihydrate M20 EP/USP Powder
Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Class II · Moderate risk
1.5% Glycine Irrigation
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Class II · Moderate risk
0.9% Sodium Chloride Irrigation
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Class II · Moderate risk
20% Dextrose Injection
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Class II · Moderate risk
5% Dextrose and 0.45% Sodium Chloride Injection
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Class II · Moderate risk
5% Dextrose Injection USP
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Class II · Moderate risk
0.45% Sodium Chloride Injection
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Class II · Moderate risk
70% Dextrose Injection USP
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Class II · Moderate risk
LifeGas OXYGEN COMPRESSED UN1072 USP
CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders.
Class II · Moderate risk
Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable)
Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
Class II · Moderate risk
Octreotide Acetate Injection
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
Class II · Moderate risk
Midazolam HCl Injection
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
Class II · Moderate risk
Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
Class II · Moderate risk
Epinephrine Injection
Presence of Particulate Matter
Class II · Moderate risk
ChloraPrep One-Step
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Class II · Moderate risk
Multihance Multipack
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel