Class II · Moderate risk
Donnatal Extentabs
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Ethambutol Hydrochloride Tablets
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Class II · Moderate risk
"Well at Wallgreens" Regular Strength Antacid Liquid
Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
Class III · Low risk
Camila (norethindrone tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Errin (norethindrone tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Balziva (norethindrone and ethinyl estradiol tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Jolessa (levonorgestrel/ethinyl estradiol tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Junel
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Lessina (Levonorgestrel and ethinyl estradiol tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class II · Moderate risk
All Compounded Products
Lack of Assurance of Sterility; potential for mold contamination
Class I · High risk
Magnesium Sulfate 2 grams in Dextrose 5% for Injection
Non-Sterility; mold contamination
Class III · Low risk
Camrese (Levonorgestrel/Ethinyl Estradiol Tablets)
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Class III · Low risk
Seasonale (Levonorgestrel/Ethinyl Estradiol Tablets)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Class III · Low risk
Liothyronine Sodium Tablets
Failed Impurities/Degradation Specifications: 3 month stability testing.
Class III · Low risk
Jolessa (levonorgestrel/ethinyl estradiol)
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Class III · Low risk
Portia (levonorgestrel and ethinyl estradiol)
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Class II · Moderate risk
Avastin
Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes
Class I · High risk
Night Bullet Capsules
Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug.
Class III · Low risk
Acetic Acid Otic Solution
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Class II · Moderate risk
Lisinopril and Hydrochlorothiazide Tablets
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer
Class II · Moderate risk
Oxiracetam & Choline
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class II · Moderate risk
BoostYourGrade.com
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class II · Moderate risk
Brain Defogger
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class II · Moderate risk
Piracetam & Choline
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class II · Moderate risk
Aniracetam and Choline
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs