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| The United States: Jubilant Cadista Pharmaceuticals Inc. issues voluntary nationwide recall of Drospirenone and Ethinyl Estradiol Tablets, USP, due to out-of-specification dissolution test results (English only) |
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The US Food and Drug Administration (FDA) announces that Jubilant Cadista Pharmaceuticals Inc. is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02mg, 28x3 Blister Pack/Carton to the consumer level. The affected product is being recalled due to out-of-specification (OOS) dissolution results at the 3-month stability time point. The affected product is manufactured by Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain under contract from Jubilant Cadista Pharmaceuticals Inc., 207 Kiley Drive Salisbury, Maryland 21801.
As a result of the OOS dissolution results, product efficacy may be decreased due to incomplete absorption of the active ingredients. To date, Jubilant Cadista Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.
Drospirenone and Ethinyl Estradiol Tablets are packaged into a carton containing 3 blister cards. Each blister card contains 28-film coated, biconvex tablets, in the following order: 24 active pink-color round, unscored, film-coated tablets debossed with a “20” on one side, each containing 3 mg drospirenone and 0.02 mg ethinyl estradiol, and four (4) inert white-color round, unscored, film-coated tablets debossed with a “PL”.
The affected Drospirenone and Ethinyl Estradiol Tablets, USP, has been identified as lot number 183222, and expiration date of 11/2020.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jubilant-cadista-pharmaceuticals-inc-issues-voluntary-nationwide-recall-drospirenone-and-ethinyl
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Jul 25, 2019
Issued at HKT 16:00
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