Qualitest Birth Control Pills Recalled For Packaging Error

Qualitest Pharmaceuticals just issued another nationwide, retail-level drug recall, the U.S. Food and Drug Administration (FDA) just announced. In this case, multiple lots of birth control pills are being recalled because of a packaging error in which 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.

This packaging error and the potential for this error to have affected other oral contraceptive products resulted in the recall of multiple lots. Because 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. While the packaging defects do not pose any immediate health risks, consumers exposed to affected packaging should immediately begin using a nonhormonal form of contraception and should consult their health care provider or pharmacist. Pharmacies are being instructed to contact consumers who received the recalled product. The source of the error is under investigation.

The recall is effective immediately and includes the following. Lot numbers—which can be found on the bottom of the box or individual blister card—can be accessed at: http://www.qualitestrx.com/pdf/OCRecall.pdf:

• Cyclafem™ 7/7/7 and Cyclafem™ 1/35
• Emoquette™
• Gildess® FE 1.5/30 and Gildess® FE 1/20
• Orsythia™
• Previfem ®
• Tri-Previfem®

Doctors, pharmacists, or women seeking additional information on this recall, or consumers in possession of the recalled drugs, can reach Qualitest, toll-free, at 1.877.300.6153 from 8:00 a.m. to 5:00 p.m., Central Time (CT), Monday through Friday.

Adverse reactions or quality problems experienced with the use of these products may be reported to Qualitest at its toll free number or to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax: Online at www.fda.gov/medwatch/report.htm; by regular mail, use postage-paid, pre-addressed Form FDA 3500 available at: 
www.fda.gov/MedWatch/getforms.htm and mail to address on the pre-addressed form; or fax: 1.800.FDA.0178.

This is not the first time we have written about packaging problems at Qualitest Pharmaceuticals. In June, Qualitest Pharmaceuticals issued a nationwide, retail-level drug recall of Butalbital, Acetaminophen, and Caffeine Tablets because a bottle of Butalbital, Acetaminophen, and Caffeine Tablets was found incorrectly labeled with an Hydrocodone Bitartrate and Acetaminophen Tablets label. Because the recalled bottles may contain incorrect tablets, patients could unintentionally take Butalbital and caffeine instead of Hydrocodone; Acetaminophen is in both preparations. In February, Qualitest Pharmaceuticals issued a voluntary nationwide drug recall of some of its Hydrocodone Bitartrate and Acetaminophen Tablets and its Phenobarbital Tablets because an individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets was found incorrectly labeled with a Phenobarbital Tablets.

And, in late 2009, Qualitest Pharmaceuticals issued a recall for all of its Accusure® Insulin Syringes because the recalled syringes may have needles which detach from the syringe. According to the recall notice, if the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection.

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