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Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Product contains undeclared Yellow 5.
Packaging defect: blister packaging inadequately sealed.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Subpotent drug
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Lack of Assurance of Sterility
PEG-40 not declared as an ingredient on the label
This recall involves PhysiciansCare brand Allergy caplets with item number 90036, Allergy Plus tablets with item number 90091, and Cold and Cough tablets with item numbers 90092 and 90033. They are packaged in boxes of 50, 100 and 250 tablets/caplets. The item numbers are printed on the top right corner of the box. The recall includes the following: Item Number Description 90036 PhysiciansCare Allergy; 50 caplets 90091 PhysiciansCare Allergy Plus; 100 tablets Non-Drowsy Cold and Cough; 100 tablets 90033 PhysiciansCare Cold and Cough; 250 tablets
Failed Impurities/Degradation Specifications