Glenmark Pharmaceuticals has issued a voluntary nationwide recall in the US for seven lots of its oral contraceptive Norgestimate and Ethinyl Estradiol tablets due to a packaging error.
The recall is issued by the company's US arm Glenmark Generics Inc for tablets in strengths of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, Glenmark Pharma said in a statement.
'The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch,' it added.
As a result of the error, the daily regimen for these oral contraceptives could leave women consumers in US at risk for unintended pregnancy, the company said.
It, however, did not mention the financial implications of the recall exercise.
The tablets are manufactured and packaged by Glenmark Generics Ltd India and are distributed by Glenamrk Generics Inc only in US, it added.
The company said it discovered the error when it received a complaint from a consumer stating that she received one blister pack in which the tablets were packaged in reverse order and it immediately decided to recall the affected packs.
'At this time, there remains sufficient supply of unaffected lots of material in the marketplace to support demand, Glenmark said.
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The recall is issued by the company's US arm Glenmark Generics Inc for tablets in strengths of 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, Glenmark Pharma said in a statement.
'The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch,' it added.
As a result of the error, the daily regimen for these oral contraceptives could leave women consumers in US at risk for unintended pregnancy, the company said.
It, however, did not mention the financial implications of the recall exercise.
The tablets are manufactured and packaged by Glenmark Generics Ltd India and are distributed by Glenamrk Generics Inc only in US, it added.
The company said it discovered the error when it received a complaint from a consumer stating that she received one blister pack in which the tablets were packaged in reverse order and it immediately decided to recall the affected packs.
'At this time, there remains sufficient supply of unaffected lots of material in the marketplace to support demand, Glenmark said.
....more info