BETHESDA, MD 29 April 2013—The Apotex Corp. recall of pharmacy bulk packages of piperacillin and tazobactam for injection now encompasses 15 lots of the antibacterial combination, the company announced April 26.
An earlier recall of the product, in March (PDF), concerned 7 lots.
The pharmacy bulk packages, containing 36 g of piperacillin and 4.5 g of tazobactam, are labeled for use by pharmacies to prepare multiple i.v. admixtures in glass and plastic containers. Apotex said the antibacterial combination, after reconstitution and transfer to containers for infusion, may precipitate or crystallize in an i.v. bag or administration line.
The recall now affects the following lots: 503B015, 503B016, 503B019, 503B020, 503B021, 503B022, 503B024, 503B025, 503B026, 503B027, 503C005, 503C006, 503C007, 503C008, and 503C018.
Apotex said anyone "with an existing inventory of the product should stop use and distribution, quarantine the recalled lots immediately" and call Genco at 1-877-674-2078, 7 a.m. to 5 p.m. CST Monday through Friday, to arrange for their return.
Whether this instruction also applies to the i.v. admixtures prepared from bulk packages in the 15 lots was asked of Apotex but has not yet been answered.
Hospira Inc. manufactured the bulk packages and is investigating to determine the root cause of the precipitation or crystallization, Apotex said.
The bulk packages were manufactured by Hospira in India. That company acquired the generic injectables pharmaceutical business of India-based Orchid Healthcare in 2010, according to the latter company's 2010 annual report. Orchid, the report also stated, would continue to supply the active pharmaceutical ingredients to its former generic injectables business.