Category Archives: Food & Drug Recalls

FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas

The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN).

FDA unveils plan to eliminate orphan designation backlog

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.

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.

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.