Class II · Moderate risk
LOSARTAN POTASSIUM Tablets
Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning
FDA drug recalls in 2014
Every FDA drug recall initiated in 2014, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,309 recalls, newest first.
Class II · Moderate risk
phosLo (calcium acetate)
Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..
Class III · Low risk
Oxandrolone Tablets
Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.
Class III · Low risk
Day Time Cold & Flu
Subpotent Drug: Phenylephrine component is subpotent.
Class III · Low risk
Haloperidol Decanoate Injection
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Class III · Low risk
Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
Class II · Moderate risk
Sodium Chloride Hypertonicity Ophthalmic Ointment
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Class II · Moderate risk
Muro 128 (sodium chloride)
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.
Class I · High risk
Thinogenics
Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
Class II · Moderate risk
Gemcitabine For Injection USP
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Class II · Moderate risk
Pantoprazole Sodium
Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets
Class III · Low risk
Children's Cetirizine Hydrochloride Chewable Tablets
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Class III · Low risk
Cetirizine Hydrochloride Chewable Tablets
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Class II · Moderate risk
Tikosyn¿ (dofetilide)
Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg).
Class II · Moderate risk
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Class II · Moderate risk
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets
Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
Class II · Moderate risk
Sevoflurane
Failed pH Specifications: product was too acidic.
Class III · Low risk
Mercaptopurine Tablets USP
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
Class III · Low risk
Azathioprine Tablets USP
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
Class I · High risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
Class II · Moderate risk
triple therapy
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
Class III · Low risk
Psyllium Fiber
Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
Class III · Low risk
Glytone Acne
Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.