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Failed Dissolution Specifications
Lack of Assurance of Sterility
Failed Stability Specifications
Defective Delivery System
This recall involves Ferrous Sulfate Enteric-Coated Tablets dietary supplements containing 324 mg of ferrous sulfate (iron) in bottles of 100 tablets. "Nationwide Pharmaceutical" and its logo are printed on the top left of the bottle's label panel. The recalled bottles include lot numbers M0786, M0816, M0817 and M0818, which are printed on the bottom of the bottle.
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
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
Sub-potent Drug
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.