Thoratec Corporation issued a voluntary urgent medical mevice correction letter to all hospitals who have patients supported with the HeartMate II LVAS, reports the FDA. The letter is reminding those hospitals to monitor the expiration date of the backup battery contained within the HeartMate II "Pocket" System Controller, as specified in the product instructions for use.
Allergan announced that it is conducting a voluntary recall down to consumer level of specific lots of its Refresh Lacri-Lube 3.5g and 7g for dry eye, Refresh P.M.
Hartley Medical is voluntarily recalling three lots of Prolotherapy with Phenol, Injectable to the hospital/user level due to non-sterility concerns, reports the FDA. The product can be identified by its white label on each vial with the name “PROLOTHERAPY WITH PHENOL," and it was distributed in California and Nevada to pain clinics between May 15, 2015 through July 14, 2015.
Unichem Pharmaceuticals (USA), Inc. (Unichem) is voluntarily recalling one lot of Hydrochlorothiazide Tablets 25 mg 1000-count bottle to the consumer level, reports the FDA. The recall has been initiated as a precautionary measure due to the identification of a Clopidogrel tablet found in a bottle of the product.
Baxter International Inc. announced it is voluntarily recalling one lot of intravenous (IV) solution to the hospital/user level due to the potential for leaking containers, particulate matter and missing port protectors, reports the FDA. Baxter was made aware of these issues through customer complaints. There have been no adverse events associated with this lot reported to Baxter to date.
Teva Parenteral Medicines announced a voluntary recall of six lots of Adrucil (fluorouracil injection, USP) 5g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals, according to an FDA press release. A similar recall occurred in May.
Life & More, L.L.C. is voluntarily recalling 783 Bottles from Lot #000185004400 Akttive High Performance Fat Burner Gold capsules weight loss supplements, reports the FDA. Akttive High Performance Fat Burner Gold weight loss supplement capsules are marketed as a dietary supplement for weight loss. They are packaged in aluminum bottles containing 30 gold capsules per bottle and labeled with Lot #000185004400, UPC 859189005005, Expiration 12/17.
Baxter International Inc. announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter, according to a July 17 FDA press release. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint.
The FDA reports that some units of Mylan Institutional's previously recalled lots of Calcium Chloride Intravenous Infusion pre-filled syringes may still be on the market.
Mylan N.V. announced that its U.S.-based Mylan Institutional business is expanding its voluntary nationwide recall to the hospital/user level of select lots of the following injectable products due to the presence of visible foreign particulate matter observed during testing of retention samples, according to the FDA.