14,806 recalls, newest first
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.
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.
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
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.
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.
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.
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.
Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.