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FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

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

Sagent Pharmaceuticals, Inc. Schaumburg, IL announced on February 23, 2015 the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL 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

Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL due to FDA Observations Pertaining toAseptic and GMP Practices at the Manufacturer’s Site Potentially Impacting Product Sterility Schaumburg, … [Read more...]

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