Home » News: Pregnant Problem: FDA Orders Recall of Oral Contraceptives Due to Packaging Error
News: Pregnant Problem: FDA Orders Recall of Oral Contraceptives Due to Packaging Error
Qualitest Pharmaceuticals issued a nationwide, retail-level recall of multiple lots of oral contraceptives because a packaging error may result in the daily regimen for these products being incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. Select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible.
BACKGROUND: These packaging defects do not pose any immediate health risks. Pharmacies are being instructed to contact consumers who have received affected product.
RECOMMENDATION: Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately and consult their health care provider or pharmacist. Consumers who have affected products should contact Qualitest for information or to arrange return of any affected product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Merck Stops Development of Parkinsonís DrugFrom Bloomberg
Merck & Co. will end development of preladenant because a preliminary review of late-stage clinical trials suggests it doesnít work
French Drugmaker on Trial for Suspected DeathsFrom Yahoo! News
Servier Laboratories, French drugmaker responsible for producing diabetes and weight loss drug Mediator, faces charges for deception in relation to the suspected deaths of hundreds of people.
Novo Acquires Xellia Pharmaceuticals for $700 MillionFrom PharmaTimes Online
Novo A/S has acquired Xellia Pharmaceuticals of Norway
Royalty Increases Bid as Elan Unveils AcquisitionsFrom PharmaTimes Online
Royalty Pharma has resurfaced to raise its bid to acquire the Irish drugmaker Elan
New Asthma Drug Offers Hope for PatientsFrom Forbes
An experimental asthma drug could give new hope to patients for whom existing medicines are not enough
Syrian Pharma Production Nearly Halted by WarFrom AFP
A shortage of foreign currency has brought production to a near halt in Syria
Camfil APC Opens Manufacturing Plant in the UKFrom Camfil
Camfil announced the grand opening of its new 40,000-sq.-ft. facility
Actavis Acquiring Warner Chilcott for $8.5BFrom AP
Actavis to buy Warner Chilcott in an all-stock transaction
Northwest Analytics Launches Next Generation Enterprise Manufacturing Intelligence SolutionFrom Northwest Analytics
NWA Focus EMI Delivers Real Time Process Intelligence and Unique Accelerating Modules - a Shared Knowledge Base and Manufacturing-Centric Collaboration
Innovative Clinical Development Partnership Announced By Quintiles and Merck SeronoFrom MarketWatch.com
Agreement creates unique strategic collaboration for development and clinical trial execution
- All news »