PharmaTech LLC Issues Voluntary Nationwide Recall of Diocto Liquid Distributed by Rugby Laboratories Due to Product Contamination For Immediate Release July 15, 2016 Contact Consumers Rugby®'s Customer Support Department 1-800-645-2158 Media Brett Ludwig (215) 970-0153 Announcement View Product Photos PharmaTech LLC of Davie, FL, the … [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...]
Burkholderia cepacia: This Decision Is Overdue
FDA Believes Now is the Time to Remove the Bug from Pharmaceutical Manufacturing The FDA recently published an article wherein they discuss the rationale for removing B. cepacia from the pharmaceutical arena. They cite a number of reasons why they believe that this bacterium and its variants should no longer be permitted. These discussions are … [Read more...]
NUSIL TECHNOLOGY LLC RECEIVES FDA WARNING LETTER (032312)
API MFG CITED FOR OOS AND MICROBIOLOGICAL ISSUES (B. cepacia) -- REFERENCES RECENT PDA J. PHARM SCI & TECH 1. Your firm failed to have an adequate out-of-specification (OOS) procedure to conduct thorough and scientifically sound investigations including corrective actions. For example, the OOS report number (b)(4) for lot (b)(4) of Simethicone Emulsion USP … [Read more...]
INSIGHT PHARMACEUTICALS ISSUE VOLUNTARY NATIONWIDE RECALL DUE TO BACTERIAL CONTAMINATION
RECALL TO CONSUMER LEVEL BECAUSE OF POSSIBLE BURKHOLDERIA CEPACIA COMMENT Insight Pharmaceuticals recalled 34,092 bottles of Nostrilla Nasal Decongestant nasal spray because it may contain the bacteria Burkholderia cepacia. This bacterium, known as a "specified" microorganism, has historically been a periodic … [Read more...]
