Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Amerisource Health Services
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Failed Dissolution Specifications.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
cGMP deviations
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Failed Dissolution Specifications:
Presence of Foreign Tablets/Capsules
Presence of Foreign Tablets/Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Failed Dissolution Specifications
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
CGMP Deviations
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Failed Impurities/Degradation Specification.
Superpotent drug: Assay results were slightly above specification at the time zero point.
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Failed Impurities/Degradation Specifications
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Failed Impurities/Degradations Specifications
Subpotent Drug
Class I - Dangerous
Presence of Foreign Tablets/Capsules.
Class I - Dangerous
Failed Stability Specifications
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Class I - Dangerous
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
Presence of Foreign Tablets/Capsules
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Class I - Dangerous
Presence of Particulate Matter