💊 Drugs • 11,927 recalls
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; particulates identified during visual inspection
Hikma Pharmaceuticals USA
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
CGMP Deviations; particulates identified during visual inspection
Failed Dissolution Specifications.
Sub-Potent Drug: Subpotent assay results during stability testing.
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations; potential temperature excursions due to transit delays
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Sub-Potent Drug: Subpotent assay results during stability testing.
Lupin Pharmaceuticals
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations; potential temperature excursions due to transit delays
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations; potential temperature excursions due to transit delays
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Subpotent Drug: Assay below the approved specification
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Subpotent Drug: Assay below the approved specification
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
SUN PHARMACEUTICAL INDUSTRIES
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).