Class III · Low risk
Lemon Hand Sanitizing Wipes
CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
Class III drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
Class III · Low risk
CellCept (mycophenolate mofetil)
Short Fill: some bottles contained less than 120-count per labeled claim.
Class III · Low risk
Children's Cetirizine HCl Chewable Tablets 5 mg
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Class III · Low risk
Pramipexole Dihydrochloride Tablets
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Class III · Low risk
Pramipexole Dihydrochloride Tablets
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Class III · Low risk
Enalapril Maleate Tablet
Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Class III · Low risk
Novarel¿ (Chorionic Gonadotropin for injection, USP)
Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products.
Class III · Low risk
Venlafaxine ER 150mg
Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
Class III · Low risk
Major Oral Peroxide
Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.
Class III · Low risk
Capex Shampoo
Subpotent; fluocinolone acetonide.
Class III · Low risk
Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin
Presence of Particulate Matter; potential for charcoal particulates
Class III · Low risk
Prometh VC with Codeine Cough Syrup
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Class III · Low risk
Prometh VC Plain
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Class III · Low risk
Thallous Chloride Tl 201 Injection
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Class III · Low risk
Oasis Age Essential
Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
Class III · Low risk
Topiramate Tablets
Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".
Class III · Low risk
Tizanidine
Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Class III · Low risk
Fougera Ketoconazole Cream 2%
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
Class III · Low risk
Major brand Infants' Mapap
Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014
Class III · Low risk
Hydroxyzine Hydrochloride Oral Solution
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Class III · Low risk
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Class III · Low risk
Carboplatin Injection
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Class III · Low risk
Nexium (esomeprazole magnesium)
Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
Class III · Low risk
Famotidine Tablets USP
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
Class III · Low risk
Super Colon Cleanse
Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients per dose" Senna Leaf powder 140 mg. It should correctly be stated as "Active ingredient (in each capsule)" Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule) Senna Leaf Powder 140 mg.