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Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing ...

FDA Recall #D-1837-2019 — Class I — July 9, 2019

Recall #D-1837-2019 Date: July 9, 2019 Classification: Class I Status: Terminated

Product Description

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 Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43

Reason for Recall

Failed dissolution specifications : failed results at the 3-month stability time point.

Recalling Firm

Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

11,412 cartons/34,236 blister cards/28 tablets each card

Distribution

USA Nationwide

Code Information

Lot #: 183222, Exp 11/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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