Class III · Low risk
Depo-Medrol
Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
Cataflam (diclofenac potassium)
Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
Class II · Moderate risk
Alprazolam Tablets
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Class I · High risk
Lidocaine HCl Injection
Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
Class III · Low risk
OXYCODONE HYDROCHLORIDE C II Oral Solution USP
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
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 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