💊 Drugs • 12,141 recalls
Wedgewood Village Pharmacy
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Glenmark Pharmaceuticals Inc., USA
Defective Container
Defective container: defect prevents product from dispensing as intended.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Teva Pharmaceuticals USA
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
SUN PHARMACEUTICAL INDUSTRIES
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Washington Homeopathic Products
cGMP deviations