McGuff Compounding Pharmacy Services Thiamine Hydrochloride 200 mg/2mL (100mg/mL) recall — FDA D-0266-2023
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
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10,685 detailed records are currently available in this category.
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Lack of sterility assurance
Lack of sterility assurance
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Lack of sterility assurance
Lack of sterility assurance
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Lack of sterility assurance
Lack of sterility assurance
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Lack of sterility assurance
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Lack of sterility assurance
Lack of sterility assurance
Lack of sterility assurance
Lack of sterility assurance
Lack of sterility assurance
Lack of sterility assurance
Lack of sterility assurance
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Lack of sterility assurance
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/Degradation Specifications: High Out Of Specification degradation results.
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
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