Class II · Moderate risk
Pataday
CGMP Deviations: products were stored outside the drug label specifications.
FDA Drug Recalls
52 recalls, newest first
Class II · Moderate risk
GenTeal Tears
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Miralax (Polyethylene Glycol 3350)
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Debrox
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Systane Zaditor
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Systane Balance
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Eye-stream
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Systane
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Naphcon A eye drops
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Bisacodyl Suppositories
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Triple Antibiotic Ointment
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Hydrogen Peroxide Topical Solution
Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.
Class I · High risk
Morphine Sulfate extended-Release Tablets
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class I · High risk
Morphine Sulfate extended-Release Tablets
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class III · Low risk
Tivicay (dolutegravir)
Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
Class III · Low risk
Higher Education Make Out Ready Vegan Lip Balm
Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.
Class I · High risk
Insulin Glargine
Labeling: Missing label on the vial
Class III · Low risk
23.4% Sodium Chloride Injection
Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.
Class II · Moderate risk
The Natural Dentist Healthy Breath Antiseptic Rinse
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage Oil and has the wrong UPC
Class II · Moderate risk
Sucralfate Oral Suspension
Labeling: Label Mix-Up
Class I · High risk
Meclizine Hydrochloride Tablets USP
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Class II · Moderate risk
HEB 50% Isopropyl Alcohol First Aid Antiseptic
Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.
Class I · High risk
Morphine Sulfate PF 25 mg/25mL
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Class I · High risk
HYDROmorphone HCl PF 10 mg/50 mL
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Class III · Low risk