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.
FDA Drug Recalls
530 recalls, newest first
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 III · Low risk
Midol Complete
Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.
Class III · Low risk
Midol Complete
Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.
Class II · Moderate risk
Epinephrine Injection
Presence of Particulate Matter
Class III · Low risk
CABERGOLINE Tablets
Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
Class III · Low risk
Jolessa (levonorgestrel/ethinyl estradiol tablets, USP)
Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
Class II · Moderate risk
ChloraPrep One-Step
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Class I · High risk
X-ROCK For Men
Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).
Class I · High risk
Morphine Sulfate Injection
Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL
Class III · Low risk
Loxitane Capsules
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class III · Low risk
Loxapine Capsules USP
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class III · Low risk
Loxapine Capsules USP
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class III · Low risk
Loxapine Capsules USP
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class III · Low risk
Loxapine Capsules USP
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
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 III · Low risk
Bracco Diagnostics multihance
Short Fill: The product is being recalled due to a potential underfill of the affected vials.