FDA announces 3 big drug recalls

March 26, 2019

Several companies are recalling products due to contamination from substances such as carcinogens and glass-here’s what you should know.

 Several companies are recalling their products due to contamination from substances such as carcinogens and glass.

Here are the top 3 recalls:

  • Mylan Institutional issued a voluntary nationwide recall of 2 lots (of Levoleucovorin Injection, 250 mg./25 mL to the consumer/user level. Levoleucovorin is used to treat the side effects of the cancer treatment methotrexate.

Manufactured by Alidac Pharmaceuticals and distributed by Mylan, the drug is being recalled because of the presence of copper salts.

Related: Blood pressure drug recalls soar

“Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. Intravenous administration of a solution containing particulates could lead to local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism,” Mylan said in a press release.

However, Mylan has not received any reports of adverse events related to the recall.

   2. Hospira Inc., a Pfizer company, is voluntarily recalling certain lots of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), to the hospital level, because it may contain glass.

“The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected,” Hospira said in a statement.

Hospira Inc. has not received reports of any adverse events.

Related: Pharma maker expands ibuprofen recall

   3. Legacy Pharmaceutical Packaging is recalling 3 repackaged lots of Losartan Tablets USP 50 mg to the consumer level, because of the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), a potential human carcinogen.

Legacy’s recall was prompted by Torrent Pharmaceuticals’ voluntary nationwide recall of the blood pressure medication Losartan due to NMBA in the API ingredient in its Losartan, which was manufactured Hetero Labs Limited.

Losartan Potassium was distributed by pharmacies nationwide. Legacy is notifying its distributors and customers in writing and is arranging/assisting for return of all recalled products to Inmar Pharmaceutical Services, Legacy said in a statement.

Read more: Pharma makers recall 2 important drugs