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.
FDA drug recalls in 2012
Every FDA drug recall initiated in 2012, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
534 recalls, newest first.
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 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.