Recalls

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.

Examining Medical Device Recalls

Pouches were the most prevalent packaging type seen in a recent study of medical device recalls associated with packaging failure. “Out of 60 packaging failure types, 36 were related to pouches, which is equivalent to 60%,” explains Eric Schmohl, customer and application support manager, Tyvek, for DuPont Medical & Pharmaceutical Protection. “All other packaging types range from one to six counts of failure.”

Mislabeled Overpouch Prompts Recall of One Lot of Potassium Chloride Injection

FDA is reporting on its Web site that Baxter International Inc. is voluntarily recalling one lot of Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL because of a complaint of a mislabeled overpouch.

Convenience Sterile Surgical Packs Recalled

Convenience sterile surgical packs are being recalled after the discovery of what is being called an "adhesion defect," FDA shared via e-mail this week. 

B. Braun Medical Inc. Issues Recall Due To Particulate Matter

B. Braun Medical Inc. is voluntarily recalling one lot of 1g Cefepime for Injection USP and Dextrose Injection USP (Lot H3A744, catalog 3193-11) to the consumer level.

JCB Labs Recalls Drug Product Lots Due To Sterility Concerns

WICHITA, Kan. [Targeted News Service] -- The U.S. Department of Health & Human Services' Food & Drug Administration issued the following recall notice:
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