An error in labeling has led a generic drugmaker to recall 1.4 million packages of birth control pills.
Qualitest Pharmaceuticals, based in Huntsville, Ala., said in a statement released by the FDA that select packs of birth control had been rotated 180 degrees, (?) "reversing the weekly tablet orientation." WHAT?
The error could lead to unintended pregnancy, the release said. Oh ok, now I understand!
Eight products were included in the recall. All eight products are sold as 28-day packs, which include 21 active pills, and seven inactive placebo or reminder pills.
Dr. Tania Thomas, assistant professor of pharmacy practice at the Texas Tech University Health Science Center School of Pharmacy, said the labeling error might cause women using the products to take a placebo pill, rather than a pill containing the prescribed dosage of hormones.
"If they swapped the labels around, someone might think they're starting their new regimen, when they're actually taking pills with no hormones at all. That could result in an unintended pregnancy," Thomas said.
In addition to the incorrect weekly labels, the error also meant the lot number and expiration date on some packs was not visible.
A notification went out to all pharmacies across the nation to check their current shelf stock against the list of affected lot numbers and pull them before being dispensed.
Pharmacies were instructed to contact customers who may have received the affected packages.
Qualitest has provided a hotline (1-877-300-6153) for doctors, pharmacists and women seeking more information about the recall.
Qualitest Pharmaceuticals, based in Huntsville, Ala., said in a statement released by the FDA that select packs of birth control had been rotated 180 degrees, (?) "reversing the weekly tablet orientation." WHAT?
The error could lead to unintended pregnancy, the release said. Oh ok, now I understand!
Eight products were included in the recall. All eight products are sold as 28-day packs, which include 21 active pills, and seven inactive placebo or reminder pills.
Dr. Tania Thomas, assistant professor of pharmacy practice at the Texas Tech University Health Science Center School of Pharmacy, said the labeling error might cause women using the products to take a placebo pill, rather than a pill containing the prescribed dosage of hormones.
"If they swapped the labels around, someone might think they're starting their new regimen, when they're actually taking pills with no hormones at all. That could result in an unintended pregnancy," Thomas said.
In addition to the incorrect weekly labels, the error also meant the lot number and expiration date on some packs was not visible.
A notification went out to all pharmacies across the nation to check their current shelf stock against the list of affected lot numbers and pull them before being dispensed.
Pharmacies were instructed to contact customers who may have received the affected packages.
Qualitest has provided a hotline (1-877-300-6153) for doctors, pharmacists and women seeking more information about the recall.
No comments:
Post a Comment