Particles contaminate American Regent injectables

American Regent is working two product recalls going into the new year. Both involve particle contamination in injectable products. American Regent is a division of Long Island-based Luitpold Pharmaceuticals, owned by Daiichi Sankyo.

A December 23 recall involves unexpired lots of 7.5 percent and 8.4 percent single-dose vials of sodium bicarbonate. Some of the vials contain particles. The product was distributed to wholesalers and distributors nationwide, which in turn have distributed to hospitals and other healthcare facilities. The company advises care providers to "immediately quarantine any product for return."

The sodium bicarbonate recall follows by just three days the company's callback of certain lots of dexamethasone sodium phosphate injection in multiple-dose vials. Some vials either contain particles or they may form prior to expiration date. The company, which advises immediate quarantine in this case, too, says its investigation continues and that it's in contact with the FDA.

Particle contamination has figured prominently in some recent FDA warning letters. One case involved the poor follow-up of a contract manufacturer after the discovery of particles. Hyaluron was cited for three instances of inadequate investigation into contamination involving particles as large as 8 mm in syringes and 5 mm in vials.

- here's the release for the sodium bicarbonate recall
- see the dexamethasone release


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