The QMN Weekly Bulletin
Pharmaceuticals / Quality / Postmarket Safety / Commercial Operations

Quality Issues Force Four Injectables Makers to Recall Products

Sept. 11, 2015

Four makers of injectables — Hospira, Teva, Mylan and Baxter — recalled products last month due to quality issues.

Hospira is voluntarily recalling more than 21 million units of three injectable products, by far the firm’s biggest recall this year. The drugmaker’s biggest culprit is the nonsteroidal anti-inflammatory drug ketorolac tromethamine injection, with 20.69 million single-dose vials being recalled because the calcium salt was crystalizing.

Hospira also recalled two lots of sodium chloride injection, comprising 314,600 bags, because of sterility issues. The sodium chloride comes in the midst of a nationwide saline shortage.

Hospira spokeswoman Julie Ferguson says the firm does not know how much product remains on the market, as it does not track it once it leaves the warehouse.

Insects found in IV solutions forced Baxter International to voluntarily recall two lots of product, the firm’s seventh recall of an intravenous solution since December 2013.

Sodium chloride injection is again the focus of the recall — as it has been in five other of the seven particulate-induced recalls. Both lots involve 0.9 percent sodium chloride injection, one in a Viaflex plastic container and the other in a Mini-Bag Plus container. In April, Baxter was forced to recall 15 lots, or roughly 237,000 units, of sodium chloride because of particulates.

Baxter did not return a request for comment by press time.

Mylan Continues Calcium Chloride Recalls

Mylan is continuing its recall of 14 lots of calcium chloride prefilled syringes that are incompatible with certain needleless adaptors, issuing a second letter in June after learning the product may still be on the market.

The lots involved were manufactured in India and distributed in the U.S. between March 2014 and February 2015. The ongoing recall is the latest in a series of recalls involving products produced at Mylan facilities in India.

Teva Recalls Adrucil Again

Particulates have forced Teva to voluntarily recall lots of its anticancer therapy Adrucil for the second time since May, after silicone rubber pieces from a filler diaphragm and fluorouracil crystals were found in six lots of the product, totaling over 30,000 vials.

In early May, Teva recalled eight lots of the drug after finding the same types of particulates in vials. Teva spokeswoman Michele Pelkowski said the two recalls are related, and the cause is still being investigated.

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