Published in The Voice.
Glenmark issues recall of birth control pills
By Sharon Weltz
Glenmark Generics Inc. announced on Friday, February 24, that it is recalling seven lots of generic birth control pills because they were packaged out of sequence, rendering them ineffective.
"As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy," Glenmark said in a statement.
According to the FDA, this recall is being implemented because “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. Any blister for which the lot number and expiry date is not visible is subject to recall.”
The affected lots were sent to wholesalers and pharmacies in the United States between Sept. 21, 2011 and Dec. 30, 2011, and have the Glenmark logo imprinted on the blister pack. Glenmark said it discovered the packaging problem after a customer complained that one of her blister packs had the pills packaged in reverse order
The blister packs contain four rows of different colored pills. Consumers should examine their packets to determine if tablets are in correct sequence. The correct color tablet sequence begins with a row of white pills labeled Start. The second row contains light blue pills labeled Week 2. The third row contains darker blue pills labeled Week 3, and the forth row contains green pills labeled Week 4.
The lot numbers on the packets are: 04110101, 04110106, 04110107, 04110114, 04110124, 04110129 and 04110134. Glenmark did not specify how many packets were affected.
"Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately," Glenmark says in a news release. "Patients who have the affected product … should notify their physician and return the product to the pharmacy."
This is the second recall of birth control pills in less than four weeks. The Glenmark recall is not linked to the earlier recall of birth control pills manufactured by Pfizer.
Glenmark Generics Inc. announced on Friday, February 24, that it is recalling seven lots of generic birth control pills because they were packaged out of sequence, rendering them ineffective.
"As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy," Glenmark said in a statement.
According to the FDA, this recall is being implemented because “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. Any blister for which the lot number and expiry date is not visible is subject to recall.”
The affected lots were sent to wholesalers and pharmacies in the United States between Sept. 21, 2011 and Dec. 30, 2011, and have the Glenmark logo imprinted on the blister pack. Glenmark said it discovered the packaging problem after a customer complained that one of her blister packs had the pills packaged in reverse order
The blister packs contain four rows of different colored pills. Consumers should examine their packets to determine if tablets are in correct sequence. The correct color tablet sequence begins with a row of white pills labeled Start. The second row contains light blue pills labeled Week 2. The third row contains darker blue pills labeled Week 3, and the forth row contains green pills labeled Week 4.
The lot numbers on the packets are: 04110101, 04110106, 04110107, 04110114, 04110124, 04110129 and 04110134. Glenmark did not specify how many packets were affected.
"Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately," Glenmark says in a news release. "Patients who have the affected product … should notify their physician and return the product to the pharmacy."
This is the second recall of birth control pills in less than four weeks. The Glenmark recall is not linked to the earlier recall of birth control pills manufactured by Pfizer.