Class II · Moderate risk
Children's Q-Pap
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Children's Q-Pap
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
Class II · Moderate risk
ZyGenerics ATENOLOL Tablets
Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
Class II · Moderate risk
ProSol - sulfite-free
Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).
Class II · Moderate risk
CYTARAbine for Injection USP
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; complaints of mold in the overpouch
Class II · Moderate risk
Alprazolam Tablets
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Class II · Moderate risk
Alprazolam Tablets
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Class II · Moderate risk
Wockhardt Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
Class II · Moderate risk
Fagron
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Class II · Moderate risk
Fagron
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Class II · Moderate risk
Fagron
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Class II · Moderate risk
Tetrahydrozoline Hydrochloride
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class II · Moderate risk
All sterile products within expiry
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
Class II · Moderate risk
Tetrahydrozoline HCL
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class II · Moderate risk
Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL
Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Benicar HCT Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Class II · Moderate risk
Benicar HCT Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Class II · Moderate risk
Benicar Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Class II · Moderate risk
Welchol Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk
Tribenzor Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk
Benicar HCT Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk
Benicar Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk
Azor Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping