Class II · Moderate risk
Acetylcysteine 10 % Solution
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
Disulfiram Tablets USP 250 mg
CGMP Deviation; cotton coil is missing in some packaged bottles
Class III · Low risk
Tizanidine Tablets USP
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Class I · High risk
Piperacillin and Tazobactam for Injection
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Class III · Low risk
Camila 0.35 mg Tablets
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Oxcarbazepine Tablets
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Class III · Low risk
Cherry Cepacol Sore Throat Lozenges
Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
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.
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.