Drugs | N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133 | Lot #: 86513, Exp 07/23/2014 | Class I | Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense. | Unique Pharmaceutical, Ltd |
Drugs | All sterile products within expiry | All Lots | Class II | Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile. | Unique Pharmaceutical, Ltd |
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, October 16, 2014
FDA Enforcement Report 10/15/2014 Includes Unique Pharmaceutical, Ltd Issues Regarding non-sterile drug testing positive for Herbas pirillum huttiense and lack of sterility assurance in Class II drugs
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