Jubilant Cadista Recalls Drospirenone and Ethinyl Estradiol Tablets for Dissolution Failure

Plain-English summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg. The affected product is packaged in cartons containing three blister cards, with each card holding 28 film-coated, biconvex tablets. The recall involves 11,412 cartons, which equates to 34,236 blister cards. The specific lot number is 183222, with an expiration date of 11/2020. The product was distributed nationwide in the United States.

The recall was initiated because the tablets failed to meet dissolution specifications. Specifically, the product failed results at the 3-month stability time point. Dissolution testing ensures that the medication releases its active ingredients at the correct rate and amount in the body. Failure to meet these specifications may result in the medication not working as intended.

Consumers and healthcare providers should discontinue use of the affected tablets and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product

Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadis

Manufacturer

Jubilant Cadista Pharmaceuticals, Inc.

Category

Drug — Oral Contraceptive

Hazard

• dissolution-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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