Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and responding to all new requests for designation within 90 days of receipt during his testimony before a Senate subcommittee.
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PharMEDium Services Issues Voluntary Nationwide Recall of Specific Lots of Potassium Phosphate and Succinylcholine Chloride Due to a Lack of Sterility Assurance
PharMEDium Services is conducting a limited, voluntary recall due to Hospira Inc.’s (“Hospira”) June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance. The products being recalled by PharMEDium Services were compounded using certain Hospira products.
Global Lamsheng Kee Inc. Issues Allergy Alert on Undeclared Egg in Frozen Fish Tofu, Frozen Fried Fish Ball and Frozen White Fish Ball
Global Lamsheng Kee Inc., Brooklyn, NY is recalling Frozen Fish Tofu, Frozen Fried Fish Ball and Frozen White Fish Ball because they may contain undeclared egg. People who have allergies to egg run the risk of serious or life-threatening allergic reaction if they consume these products.
FDA Tackles Drug Competition to Improve Patient Access
Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry
of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the
first time, a new policy to expedite the review of generic drug applications where competition is limited.
Statement from FDA Commissioner Scott Gottlieb, M.D., on the importance of the Drug Quality and Security Act and overseeing the safety of compounded drugs
In late 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history, involving hundreds of people, in many states, who developed fungal infections related to a compounded product. It was an incident that resulted in dozens of deaths.
Publix Recalls Publix Tropical Medley Mix Due to Possible Contamination with Listeria monocytogenes
Publix Super Markets is issuing a voluntary recall for Publix Tropical Medley Mix because it may be adulterated with Listeria monocytogenes. Publix received notification of the potential contamination from our supplier of dried apricot, The 5.7oz clear plastic containers of the mix were sold from Publix retail produce departments in Florida, Georgia, South Carolina, Alabama, Tennessee and North Carolina with a UPC of 41415088586. All use by dates are being recalled.
Publix Recalls Publix Tropical Medley Mix Due to Possible Contamination with Listeria monocytogenes
Publix Super Markets is issuing a voluntary recall for Publix Tropical Medley Mix because it may be adulterated with Listeria monocytogenes. Publix received notification of the potential contamination from our supplier of dried apricot, The 5.7oz clear plastic containers of the mix were sold from Publix retail produce departments in Florida, Georgia, South Carolina, Alabama, Tennessee and North Carolina with a UPC of 41415088586. All use by dates are being recalled.
ADM Animal Nutrition Recalls Rough-N-Ready Cattle Feed A specific lot of product contains elevated levels of monensin, could harm cattle
ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 50-pound bags of Rough-N-Ready 14 BT cattle feed, product number 54787BHB24, because the product contains elevated levels of monensin beyond the recommended dosage, which could be harmful to cattle. At elevated levels, monensin can be toxic to cattle and can cause colic-like symptoms, hypokalemia, myoglobinuria, chronic cardiovascular issues, and possible death.
Fagron Sterile Services Issues Voluntary Nationwide Recall of Succinylcholine Chloride Due to Potential For Lack of Sterility Assurance
Fagron Sterile Services is voluntarily recalling three (3) lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level. The secondary recall of product manufactured by Hospira Inc., a Pfizer company, and repacked by Fagron Sterile Services is due to microbial growth detected during a routine simulation of Hospira’s manufacturing process, which represents the potential introduction of microorganisms into the product.
Teleflex’s (TFX) Vascular Solutions, Inc. Issues Recall of Venture® Catheters
Teleflex Incorporated (NYSE: TFX), announces a worldwide recall of Venture® Catheters was voluntarily initiated by its Vascular Solutions, Inc. subsidiary on April 25, 2017. Vascular Solutions, Inc. is the manufacturer of Venture Catheters, which are designed for use in catheterization procedures, to direct, steer, control, and support a guidewire to access discrete regions of the coronary and peripheral vasculature. Two versions may also be used for manual delivery of saline solution or diagnostic contrast agents.