Recalls

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.

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.

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.

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. 

Mylan Expands Voluntary Nationwide Recall of Select Lots of Injectable Products Due to the Presence of Particulate Matter

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.

SmartLipo365 Issues Voluntary Nationwide Recall of Smart Lipo Capsules

SmartLipo365 is voluntarily recalling 122 lots of Smart Lipo (800, 900, 950 mg) capsules, to the consumer level, reports the FDA

The agency received samples of 800 and 900mg capsules of Smart Lipo and the lab results found the Smart Lipo products to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

Baxter Issues Voluntary Recall of Select Product Codes of Peripheral Vascular Patch

Baxter International Inc. announced it is voluntarily recalling four product codes of its VASCU-GUARD Peripheral Vascular Patch, according to the FDA. The company received customer complaints of difficulty in distinguishing the smooth from rough surface of the VASCU-GUARD patch as described in the labeled instructions for use. The FDA states this is due to a deviation in the surface texture of the vascular patch in a new packaging configuration.

Teva Parenteral Medicines Initiates Voluntary Nationwide Recall of Select Lots of Adrucil

Teva Parenteral Medicines announced a voluntary recall Tuesday of eight lots of Adrucil (fluorouracil injection, USP) 5 g/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

Iron Oxide Found in Hospira Bupivacaine HCl Injection Lot, Voluntary Nationwide Recall Issued

Illinois-based Hospira, Inc. announced Thursday it is issuing a voluntary recall of one lot of preservative-free Bupivacaine hydrochloride injection, USP, 0.5 percent (5 mg/mL), 30 milliliter single-dose due to one confirmed customer complaint of orange and black visible particles embedded and free-floating within a single-dose glass tear top vial, according to an FDA news release.

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