The FDA on April 11, 2016 notified pharmaceutical, Pharmakon Pharmaceuticals, Inc, Noblesville, IN that all sterile operations at their facility should cease until appropriate corrective actions have been implemented by the facility and recall all non-expired drug products that are intended to be sterile. A day later (April 12, 2016), Pharmakon informed FDA that it … [Read more...]
Another Sunscreen Manufacturer (Jaychem Industries, Ltd.) Receives Warning Letter (090415)
The FDA identified significant violations of current good manufacturing practice (CGMP) regulations during an audit (July 7-10, 2014) of Jaychem Industries, Ltd., Auckland New Zealand and their finished pharmaceuticals, Unfortunately, several other firms to include W.S. Badger Co (Click here) (September 23, 2013), a sunscreen manufacturer, had a huge recall for … [Read more...]
Sagent Pharmaceuticals Recall due to FDA Observations Pertaining to Aseptic and GMP Practices at the Manufacturer’s Site Potentially Impacting Product Sterility
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)
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...]
NUTEK DISPOSABLES, INC ISSUES ALERT DUE TO POTENTIAL BACTERIA IN BABY WIPES (RECALL – 10/25/14)
FOR IMMEDIATE RELEASE — Oct. 25, 2014 — MCELHATTAN, PA — Nutek Disposables, Inc. of McElhattan, PA has initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the brand names Cuties, Diapers.com, Femtex, Fred's, Kidgets, Member's Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings, because some … [Read more...]
