Class II · Moderate risk
All Compounded Products
Lack of Assurance of Sterility; potential for mold contamination
FDA Drug Recalls
1,969 recalls, newest first
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
Class II · Moderate risk
Nootropa Cognitive Enhancement Supplement
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class II · Moderate risk
Aniracetam & Choline capsules
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Class II · Moderate risk
Rifadin
Subpotent drug: low fill volume in some of the capsules
Class III · Low risk
4 way Saline Moisturizing Mist with Eucalyptol & Menthol
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class III · Low risk
4 way Nasal Decongestant Menthol Nasal Spray
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class III · Low risk
4 way Nasal Decongestant Fast Acting Nasal Spray
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class III · Low risk
Nupercainal
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class III · Low risk
Myoflex (trolamine salicylate)
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class II · Moderate risk
Venlafaxine Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.