Class II · Moderate risk
Fagron
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
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 I · High risk
Epel 18 mg Estradiol Pellet
Non-Sterility: The recalled lot failed sterility testing.
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 I · High risk
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
Class II · Moderate risk
Tetrahydrozoline HCL
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk
Clonidine HCl Injection
Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".
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 III · Low risk
buPROPion HCl Extended-Release Tablets
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
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
Class I · High risk
Potassium Chloride Injection
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
Class I · High risk
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
Class III · Low risk
Orphenadrine Citrate Extended Release Tablets
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Class I · High risk
LACTATED RINGER'S and 5% DEXTROSE Injection USP
Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
Class II · Moderate risk
Clonidine HCL
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.