lorida- Andropharm is voluntarily recalling all lots of Sten Z and M1 Alpha capsules to the consumer level because these products contain derivatives of anabolic steroids rendering them unapproved drugs for which safety and efficacy have not been established and therefore subject to recall.
Biohealth Nutrition of San Dimas, CA is recalling Precision Blend Cookies & Cream because product labels failed to declare the food allergen, wheat. People who have an allergy or severe sensitivity to wheat run the risk of a life threatening allergic reaction, anaphylaxis, that requires immediate medical attention should they consume products containing allergens.
Coborn’s, Inc. of St. Cloud, Minn. is recalling packages of its Gluten Free Chocolate Chip Bars, some of which were incorrectly labeled as Gluten Free Fudge Brownies. The Gluten Free Fudge Brownie label does not indicate the product contains milk, however the Gluten Free Chocolate Chip Bars that are incorrectly labeled as Gluten Free Fudge […]
The U.S. Food and Drug Administration today approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder.
During the use of some ATAR extension cables, the cable was separating from the connector at the proximal end. The analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use.
Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo® batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents. NovoPen Echo® is used for insulin treatment by people with diabetes. Using a device with a cracked/broken cartridge holder may result […]
U.S. District Judge William H. Steele entered a consent decree of permanent injunction yesterday between the United States and Medistat RX LLC of Foley, Alabama, the company’s co-owners, Mark D. Acker and Timothy L. Fickling, and quality manager and pharmacist-in-charge V. Elaine Waller.
Clif Bar & Company is initiating a voluntary recall of CLIF® BUILDER’S® Bar Chocolate Mint flavor, and CLIF Kid Zbar® Protein Chocolate Mint and CLIF Kid Zbar® Protein Chocolate Chip flavors due to possible presence of undeclared peanuts and some tree nuts, including almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, walnuts and coconuts. Clif […]
Hardcore Formulations is voluntarily recalling all lots and expiration dates of Ultra-Sten and D-Zine capsules to the consumer level. These products are labeled to contain methylstenbolone (Ultra-Sten) and dymethazine (D-Zine), which are considered to be derivatives of anabolic steroids. The presence of these anabolic steroids in Ultra-Sten and D-Zine render them unapproved drugs for which […]
Raja Foods LLC of Skokie, Il is recalling its 15 ounce package of “ANARKALI PESHAWARI NAAN” because they may contain undeclared MILK. People who have allergies to MILK run the risk of serious or life-threatening allergic reaction if they consume these products.
Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors.
St Louis-based Dierbergs is recalling various Deli Products with multiple use by dates in all retail stores because undeclared fish (anchovy) in a Caesar dressing and undeclared milk in 2 Santa Fe wraps. People who have allergies to fish and dairy run the risk of serious or life-threatening allergic reaction if they consume these products.
A New York smoked fish company has been ordered by a federal court to stop selling its products, which were produced in a facility that was contaminated with Listeria monocytogenes (L. mono), until it can comply with food safety regulations.
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).
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 […]
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., 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.
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 […]
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.