The following recalls have been announced:
Qualitest Pharmaceuticals Inc. is recalling two lots of Accusure insulin syringes because the products’ needles can detach from the syringes. When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection, the Huntsville, Ala., company said.
The company is aware of three complaints, including reports of the needle sticking in the skin after the insulin was administered and the needle sliding back into the syringe, spokeswoman Julie Schwarz said.
The recall involves Accusure Insulin Syringes (1/2 cc - 31 G - Short Needle) with lot number 6JCB1 and NDC 0603-7001-21. This lot was distributed between January and June 2007 to wholesalers and retail pharmacies nationwide and in Puerto Rico.
Also recalled are Accusure Insulin Syringes (1 cc - 31 G - Short Needle) with lot number 7CPT1 and NDC 0603-7002-21. This lot was distributed between May 2007 and June 2008 to wholesalers and retail pharmacies nationwide and in Puerto Rico.
The lot number can be found on the white paper backing of each individual syringe. Consumers who have these products should stop using them and contact the company at 800-444-4011 for product replacement instructions. Adverse reactions can be reported to the Food and Drug Administration at www.fda.gov/medwatch/report.htm.
Nutracoastal Trading LLC announced it is expanding its July 28 voluntary nationwide recall of the company’s dietary supplement product sold under the following name: STEAM.
The Company has found by lab analysis that Lot 90260 contains Tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making STEAM Dietary Supplement an unapproved drug. The active drug ingredient is not listed on the product label. The undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.
The recalled product listed below was distributed in white plastic bottles to retail stores nationwide: Brand Name, STEAM; Size (1 Bottle - 5 Capsules); Lot, 90260; Exp., 6 11; UPC, 8 52263 30033 1.
No illnesses have been reported to the company to date in connection with this product.
Consumers should return any unused product to the retail location where they were purchased or contact Nutracoastal Trading LLC directly at 866-803-2434 Monday - Friday, 9 a.m. to 5 p.m. EDT.