A packaging error may cause consumers to take a placebo pill instead of an active pill, which could lead to an unintended pregnancy. The faulty blister packs contain too many pill slots, so recipients may have too many placebos or an empty pill space. The manufacturer Apotex Corp. has issued a voluntary nationwide recall of Drospirenone and Ethinyl Estradiol tablets from four different production lots.
NDC number on out carton: 60505-4183-3
NDC number on inner carton: 60505-4183-1
Lot numbers: 7DY008A, 7DY009A, 7DY010A, 7DY011A
Expiration date: 8/2020
Strength: 3MG/0.03MG
The FDA website issued the following statement regarding the recall:
Weston, Florida, Apotex Corp. is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany.
Risk Statement : As a result of this packaging error, where a patient does not take a tablet due to a missing tablet or that a patient takes a placebo instead of an active tablet, loss of efficacy is possible due to variation in the dosage consumed. To date, no case has been reported for pregnancy and adverse event to Apotex.
Patients who have received impacted lots of Drospirenone and Ethinyl Estradiol Tablets, USP 3MG/0.03MG. or have questions regarding this recall please contact your pharmacy. Individuals should not interrupt their therapy, use a non-hormonal method of birth control, contact their health care provider for medical advice and may return the impacted packages to their pharmacist.
Consumers with questions regarding this recall can contact Apotex corp. by phone-number 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Photo: FDA's Flickr Photostream