Class III · Low risk Terminated
Phytonadione Tablets 5 mg
Reason Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Ketamine HCl Injection Solution
Reason Labeling: Incorrect Exp. Date: Incorrect BUD.
Class III · Low risk Terminated
Phytonadione Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Mephyton
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Class III · Low risk Terminated
Levetiracetam Tablets USP
Reason Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam
Class III · Low risk Terminated
Readyprep Chg
Reason Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Class III · Low risk Terminated
Sirolimus Tablets 1 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Cequa
Reason Subpotent and Presence of Particulates .
Class III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Class III · Low risk Terminated
Thiamine HCl Injection
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
Class III · Low risk Terminated
Olmesartan Medoxomil Tablets
Reason Presence of Foreign Tablet/Capsule
Class III · Low risk Terminated
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk Terminated
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk Terminated
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk Terminated
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk Terminated
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk Terminated
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk Terminated
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk Terminated
Hydrocodone Bitartrate and Homatropine Methlybromide tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Acyclovir Tablets
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Evrysdi
Reason Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
Class III · Low risk Terminated
Asenapine Sublingual Tablets
Reason Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class III · Low risk Terminated
Asenapine Sublingual Tablets
Reason Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class III · Low risk Terminated
Dry Eye Test
Reason Subpotent Drug