FDA

Allergan Issues Voluntary Nationwide Recall on Specific Lots Of Refresh Lacri-Lube, Refresh P.M., FML, and Blephamide For Particulate Matter

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.

FDA Cites Security Issue, Takes GUDID System Offline

The FDA’s Global Unique Identification Database (GUDID) was taken offline in early August due to a “security vulnerability,” reports sister publication Qmed.

Hartley Medical Issues Voluntary Recall of Prolotherapy with Phenol

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 Issues Recall of Hydrochlorothiazide Tablets

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 Initiates Voluntary Nationwide Recall of One Lot of IV Solution

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.

Novo Nordisk’s FlexPro PenMate Hides Needle During Injection

Novo Nordisk announced the FDA’s approval of FlexPro PenMate, designed for users of Norditropin FlexPro 5 mg, 10 mg, and 15 mg pens who dislike needles and prefer them to be hidden during the injection process. 

Teva Parenteral Medicines Recalls 6 Lots of Adrucil Due to Particulate Matter

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 Issues Nationwide Voluntary Recall of Akttive High Performance Fat Burner Gold Capsules

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.

Hospira Announces U.S. Launch of Generic Bivalirudin for Injection

Hospira Inc. has received the FDA’s approval to launch bivalirudin for injection, which is a generic version of The Medicines Company’s Angiomax.

It is available in single-dose flip-top vial, and the company plans to launch a differentiated presentation of the 250-mg bivalirudin for injection in Hospira’s ADD-Vantage vial. 

Insects Prompt Baxter Voluntary Recall Of Two Lots Of IV Solutions

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.

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