aseptic Archives - Barry A. Friedman, PhD LLC

Sagent Pharmaceuticals Recall due to FDA Observations Pertaining to Aseptic and GMP Practices at the Manufacturer’s Site Potentially Impacting Product Sterility

March 28, 2015 By Barry Friedman Leave a Comment

SagentÂ Pharmaceuticals, Inc. Schaumburg, IL announced on February 23, 2015 the voluntary nationwide recall of two lots of AtracuriumÂ BesylateÂ Injection, USP, 50mg/5mLÂ single-dose vials (NDCÂ 25021-659-05) and four lots of AtracuriumÂ BesylateÂ Injection, USP, 100mg/10mLÂ multi-dose vials … [Read more...]

SAGENT PHARMACEUTICALS INITIATES INJECTABLE RECALL DUE TO ASEPTIC AND GMP PRACTICES (2/23/15)

February 27, 2015 By Barry Friedman Leave a Comment

SagentÂ Pharmaceuticals Initiates a Nationwide Voluntary Recall of AtracuriumÂ BesylateÂ Injection, USP, 50mg/5mLÂ and 100mg/10mLÂ due to FDA Observations Pertaining toAsepticÂ and GMP Practices at the Manufacturerâ€™s Site Potentially Impacting Product Sterility Schaumburg, … [Read more...]