A New York drug company yesterday began recalling a generic drug used to treat high blood pressure after the Food and Drug Administration alleged the company submitted false information.
Interpharm Inc., of Plainview, N.Y., agreed to recall all three strengths of clonidine hydrochloride tablets from distributors and pharmacies and to conduct an audit of its 24 other products, the FDA said.
The drug comes in small, round, blue tablets marked "IP 47."
Routine testing by the FDA found that "samples of clonidine hydrochloride 0.3 milligram tablets submitted for bioequivalence testing by Interpharm were not the same as the product on the market," the agency said.
The tablets Interpharm was marketing were blue; in its application for approval the company told the FDA its tablets were blue. But the FDA said the pills it tested for bioequivalence before the drug was approved were peach-colored.
The agency said it found no data that indicated the company had ever made any peach-colored pills. The FDA said it had no evidence of a safety problem with the drug Interpharm was marketing, but questions whether the product is therapeutically equivalent to the brand name drug, Catapres, made by Boehringer Ingelheim.
FDA officials advised patients to consult their physician about switching to another product.