US recalls India-made birth control pills

A batch of birth control pills manufactured in India for US distribution has been recalled due to a packaging error that could make the pills ineffective, US health authorities said on Monday.

Seven lots of generic norgestimate and ethinyl estradiol tablets were recalled by Glenmark Generics Inc. USA, the US said.

The company said the tablets were manufactured and packaged by Glenmark Generics Ltd. India. and distributed to wholesalers and across the United States between September 21, 2011 and December 30, 2011.

"As a result of this packaging error, the daily regimen for these may be incorrect and could leave women without adequate contraception, and at risk for ," Glenmark said in a statement.

It was not immediately clear how many packets were affected by the error, which rotated some of the pills by 180 degrees out of the usual sequential order and left the lot number and expiry date visible only on the outer pouch.

"Any blister for which the lot number and expiry date is not visible is subject to recall," Glenmark added in a statement.

Doctors urged women who may have been taking the pills to immediately begin using a non-hormonal form of contraception, inform their immediately and take a if they have any symptoms of pregnancy.

"This is extremely disturbing," said Steven Goldstein, an obstetrician-gynecologist at New York University Langone Medical Center and Professor at the NYU School of Medicine, adding the recall raised new concerns about the safety of foreign-made generics.

"This problem with generics manufactured outside of the USA is of great concern to me as a clinician. I often allow and encourage patients to try generics as long as they do not have nuisance side effects however I have always assumed them of equal quality control to the branded products."

Glenmark Generics has operated its manufacturing plant in India since 2003.

The recall is the third to affect US consumers in the past six months involving contraceptives.

On February 1, US pharmaceutical giant Pfizer recalled one million packets of over a similar packaging error, though those pills were manufactured in the United States.

A separate recall was issued in September 2011 by the pharmaceutical company Qualitest in Alabama, due to packaging errors that affected 1.4 million packets of birth control pills distributed in 2011.

add to favorites email to friend print save as pdf

Related Stories

US reviews birth control pill safety over clot risk

May 31, 2011

The US Food and Drug Administration said Tuesday it is reviewing recently published studies which have pointed to an increased blood clot risk associated with a certain type of birth control pill.

Recommended for you

Using computers to design drugs

22 hours ago

Designing a new medicine is an expensive and time consuming business. Typically it takes around $2 billion and ten years for a new drug to move from its initial design in the lab, to the clinic. All the ...

Lilly psoriasis drug fares well in late-stage test

Aug 22, 2014

Drugmaker Eli Lilly and Co. said its potential psoriasis treatment fared better than both a fake drug and a competitor's product during late-stage testing on patients with the most common form of the skin disease.

New US restrictions on painkiller to take effect

Aug 21, 2014

The federal government is finalizing new restrictions on hundreds of medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.

User comments