Glenmark recalls seven lots of Norgestimate and Ethinyl Estradiol tablets
Glenmark Generics has announced a consumer-level recall of seven lots of Norgestimate and Ethinyl Estradiol tablets USP, 0.18mg/0.035mg, 0.215mg/0.035mg, 0.25mg/0.035mg, because of packaging error.
Select blisters were rotated 180 degrees within the card, which reverses the weekly tablet orientation and makes the lot number and expiry date visible only on the outer pouch.
According to the company, any blister for which the lot number and expiry date is not visible is subject to recall.
The product is used as an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Due to the packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception.
Drug Research Drug Delivery Drug Discovery & Development
Contract Research & Services Clinical Trials Contract Research Contract Services
Automation IT & Software Laboratory Instrumentation
Inward Investment Packaging Regulatory Affairs