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.
FDA drug recalls in 2013
Every FDA drug recall initiated in 2013, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
2,085 recalls, newest first.
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.
Class II · Moderate risk
FREPP/SEPP Kit containing 1 FREPP
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Class II · Moderate risk
Donor Prep Kit containing 1 FREPP
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Class II · Moderate risk
Blood Culture Prep Kit II containing 1 FREPP
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Class II · Moderate risk
SEPP 10% Povidone Iodine Solution USP
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Class II · Moderate risk
SEPP 2% Iodine Tincture USP
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Class II · Moderate risk
SEPP 70% Isopropanol
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Class III · Low risk
Voltaren 1% Gel
Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because the lot number and expiration date on the tube may not be legible.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
Class III · Low risk
Fenofibric Acid
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots