Class III · Low risk
Foradil Aerolizer
Failed Stability Specification; out of specification result for particle size distribution during stability testing
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
Vasotec (enalapril maleate)
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Class III · Low risk
Vaseretic (enalapril maleate/hydrochlorothiazide)
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Class III · Low risk
Oasis TEARS
Labeling: Missing Label; The label on the immediate bottle is missing.
Class III · Low risk
PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Class III · Low risk
PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
Class III · Low risk
Olanzapine Orally Disintegrating Tablets 5 mg
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Class III · Low risk
Triveen - PRx RNF Capsules
Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.
Class III · Low risk
Wockhardt Metoprolol Succinate
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Class III · Low risk
Children's Triacting Night Time Cold & Cough with PE
Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
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 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 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 III · Low risk
Psyllium Fiber
Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.
Class III · Low risk
Glytone Acne
Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.
Class III · Low risk
Spiriva HandiHaler
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
Class III · Low risk
Demerol
Labeling; Missing label; ampoules are missing the immediate container label
Class III · Low risk
Risperidone Oral Solution
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Class III · Low risk
Polidocanol 1% Solution
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Class III · Low risk
Papaverine 60 mg
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.