Recall targets injectable drugs

Tainted goods sold to Mid-Atlantic hospitals

Digest

September 20, 2005|By Jonathan D. Rockoff | Jonathan D. Rockoff,Sun reporter

WASHINGTON — A Lanham company is recalling all of its injectable products sold to hospitals in the region due to sterility concerns that could lead to serious injuries or death.

Central Admixture Pharmacy Services Inc., had sold the products, which included antibiotics and related medical equipment, to hospitals in Maryland, Delaware, Washington and Virginia. It drafted a letter advising the facilities to quarantine them immediately.

The company suspended sales and began recalling the products Friday after dangerous bacteria were found in two lots of a solution used to stop the heart during surgery. The next day, the Food and Drug Administration issued a notice.

It was unclear yesterday how many batches of chemicals and medical equipment would have to be recalled, and how many hospitals would be affected.

The FDA was trying to confirm that the company had sent out a warning letter it had drafted to hospitals, a spokeswoman said. The letter, which was available on FDA's Web site, did not appear to be posted on the company's Web site.

"Immediately examine your inventory and quarantine product subject to this recall," the company said in the letter. It was titled, "Urgent Drug Recall." It called on hospitals to act "to prevent patient harm."

Central Admixture Pharmacy Services is a subsidiary of B. Braun Medical Inc. of Bethlehem, Pa., according to the company's Web site. Its designated spokesman was said to be in meetings all day and not available for comment.

According to the letter, the products affected include an antibiotic for treating infections, and an antibiotic irrigation bag and bottle. Other products include drugs to induce labor during pregnancy, provide nourishment to those who cannot eat and treat serious heart problems.

The letter told hospitals to hold on to the products until told what to do. It also told customers to notify the FDA of any problems and to call the company at 301-459-9301 or 877-416-5376 with questions.

jonathan.rockoff@baltsun.com

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