FDA

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.

SSI Schaefer’s Order Verifier Streamlines Track and Trace Requirements

SSI Schaefer announced it has developed an automated solution, the SSI Order Verifier, to verify and document orders prior to shipping. The move is in response to the Drug Supply Chain Security Act and the new FDA regulations mandating distribution of pharmaceutical products require high-speed camera-based scanning, integrated with automated labeling to track and trace shipments. 

FDA Cautions Recalled Mylan Calcium Chloride Pre-filled Syringes May Still be on Market

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. 

FDA Updates Labeling and Safety Testing Guidance for Heparin-Containing Medical Devices and Combination Products

The FDA released six pages of draft guidance on labeling safety and safety testing recommendations for medical devices and combination products that include heparin.

FDA Releases Compliance Policy for Dispenser Tracing Requirements

The Federal Drug Administration released the document DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy Guidance for Industry. The guidance addresses the readiness of dispensers in the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.

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