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.
FDA Drug Recalls
129 recalls · Class III, newest first
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.
Class III · Low risk
Ritalin HCl
Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
Class III · Low risk
Ritalin HCl
Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
Class III · Low risk
Venlafaxine Hydrochloride
Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
Class III · Low risk
Advil PM Caplets
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Class III · Low risk
Nicorette Lozenge and NicoDerm CQ
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicorette (nicotine polacrilex)
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicorette (nicotine polacrilex)
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicorette Lozenge
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Class III · Low risk
Nicotine polacrilex lozenge
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.