(RxWiki News) Impax Laboratories has received a warning letter from the Food and Drug Administration in reference to batches of a cholesterol medication that failed to meet specifications.
The company voluntarily recalled five lots of a cholesterol medication after some batches failed to meet specifications in March. The lots of Femofibrate 200 mg capsules were pulled at the wholesale level following an onsite inspection at the company's California manufacturing facility conducted between Dec. 13, 2010 and Jan. 21, 2011.
"Medication was recalled at wholesale so consumers are not affected."
The warning letter cited deviations from current Good Manufacturing Practice for Finished Pharmaceuticals. Until the FDA has confirmed compliance, approval of new and pending applications at the California facility may be withheld, however, there were no restrictions placed on the company's ability to manufacture and ship pharmaceuticals.
Impax had reduced the production level during the last three months to implement changes but has since resumed to full production. There are no current plans to reduce production or hold additional drug shipments.
Impax, which manufactures 82 generic drugs and two brand products, has 15 days to respond to the FDA. The company could be subjected to additional regulatory action by the FDA if remedial actions taken are not considered sufficient.