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

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