Adverse Events and Recalls

Mylan announces a recall of eight lots of injectable products due to visible foreign particulate matter.

The company voluntarily recalls Preservative-Free Bupivacaine HCl Injection, USP due to potential iron oxide particulates.

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.

The company voluntarily recalls product due to FDA observations of potential sterility problems.

Valeant voluntarily recalled one lot of Virazole due to sterility problems; no adverse events have been reported to date.

Aurobindo Pharma USA issued a voluntary nationwide recall of Northstar Label Gabapentin Capsules, USP 300 mg, due to complaints of empty capsules.

The Baxter recall in the US of one lot of highly concentrated potassium chloride is due to a mislabeled overpouch.

Contract Packaging Resources issued a voluntary recall of naproxen sodium tablets because some cartons contain bottles of ibuprofen.

Hospira voluntary recalls certain lots of several LifeCare products due to potential for leakage.

Cubist Pharmaceuticals voluntarily recalls certain lots of CUBICIN 500 mg in 10 mL single-use vials because of the presence of particulate matter.

Sun Pharma, Forest Pharmaceuticals and West-Ward Pharmaceuticals issue recalls over dissolution issues.

Bristol-Myers Squibb issues a voluntary US recall of Coumadin (warfarin sodium) for injection due to presence of particulate matter.

Alexion initiates a voluntary nationwide recall of certain lots of soliris (eculizumab) concentrated solution for intravenous infusion because of visible particulate matter in a single lot.

Hospira announces nationwide voluntary recall of propofol injectable emulsion, USP, and lidocaine HCI injection, USP due to visible particuluates.

GSK recalls alli weight loss products in the US and Puerto Rico.

Discovery of split and broken tablets led to drug recalls.

A packaging defect has led to Merck voluntarily recalling all lots of Liptruzet tablets in the United States.

Agency issues precautionary recall due to manufacturing fault.

Agency issues precautionary recall due to manufacturing fault.

Baxter has issued a voluntary recall of one lot of nitroglycerin in 5% dextrose injection after particulate matter was found in one vial.

Boehringer Ingelheim initiates a recall due to the potential for extrinsic foreign particles in the API used to manufacture Spiriva Handihaler (tiotropium bromide inhalation powder) capsules.

FDA reports that Hospira initiated on July 12, 2013 a voluntary recall of certain lots of bupivacaine HCl due to particulates floating and/or in the glass vial.

McNeil Consumer Healthcare Division of McNeil-PPC announced a voluntary recall of three lots of Motrin Infants? Drops after 1 mm plastic particles were identified in a different product lot during manufacturing.

FDA inspections reveal possible inaccurate sterility testing.

Dr. Reddy's initiates voluntary recall of ranitidine due to microbial contamination.

The precautionary recall follows manufacturing deficiencies identified at the site in India.

Third compounding pharmacy recalls products due to FDA inspection.

Mylan issued a voluntary recall of three lots of the painkiller tablets hydrocodone bitartrate and acetaminophen.

Applying the recommendations of ICH Q10 to statistical analysis can help prevent product recalls.