Recall: Apotex Corp. Drospirenone And Ethinyl Estradiol Tablets, USP
On 2019-04-04, the FDA announced that Apotex is conducting a recall on Drospirenone And Ethinyl Estradiol Tablets, USP due to a possible missing/incorrect tablet arrangement. The recalled products were sold under the brand name(s) Apotex Corp. during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 1 drugs recalls due to potential missing/incorrect tablet arrangement. Additionally, there have been 26 drug and medical device recalls due to other health hazards as well as 85 food recalls.
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Drospirenone and Ethinyl Estradiol Tablets, USP
Brand Name(s): Apotex Corp.
Reason for Recall: Missing/Incorrect Tablet Arrangement
Official Recall Date: 2019-03-04
Additional information provided by the FDA.gov:
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. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.