LyphoMed Inc. Wednesday issued an expanded recall of up to 70 batches of gentamicin, an antibiotic, because of fears the drug could be below proper strength, a spokesman for the Food and Drug Administration confirmed.
On April 13, Rosemont-based LyphoMed recalled one lot of the drug, comprising nearly 202,000 vials, after a Department of Defense test found that some of the drug was below strength.
Gentamicin is used to treat so-called gram-negative infections, such as pneumonia or meningitis. The recalled drugs, made at the firm`s Melrose Park facility, are not classified by the FDA as posing any imminent danger to life or health.
Separately, LyphoMed sources said the company`s Orlando plant is being inspected by the FDA. A company spokeswoman called the inspection routine.
An inspection of the company`s Grand Island, N.Y., plant was completed in February. A company spokeswoman said the 19 violations of good manufacturing practice cited by the FDA were mostly minor and that the company has taken steps to correct them.
A spokeswoman for the FDA said the agency has not decided whether the problems found at the New York plant justify any action.
