Jubilant recalls lot of potentially ineffective contraceptives

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/Lina Bruins / EyeEm)
(Image: Getty/Lina Bruins / EyeEm)

Related tags: Jubilant, Recall, contraceptives, Cyndea Pharma

Jubilant voluntarily recalls one lot of contraceptive tablets due to out-of-specification dissolution results, potentially decreasing efficacy.

Jubilant Cadista Pharmaceuticals, a generics pharmaceutical company, announced the recall of the drug product, which is an estrogen/progestin combination oral contraceptive, manufactured for Jubilant by Cyndea Pharma.

Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg carton showing Product Name, NDC Number, and Company Logo. (Photo: Business Wire)
Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg carton showing Product Name, NDC Number, and Company Logo. (Photo: Business Wire)

The recalled contraceptive drugs were found with out-of-specification dissolution at the three-month stability time point, meaning that the absorption of the active ingredients by those taking the tablets may be incomplete.

Jubilant announced that the recall is being conducted with the knowledge of the US Food and Drug Administration (FDA) and that it has not received any reports of adverse events related to this recall.

Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg Blister Card Front showing lot number, expiry date, NDC number, and tablet configuration. (Photo: Business Wire)
Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg Blister Card Front showing lot number, expiry date, NDC number, and tablet configuration. (Photo: Business Wire)

The products recalled were included in the lot number 183222, with NDC number 59746-763-43, and expiration date of 11/2020. The product was distributed to wholesalers, distributors, and retailers across the US.

Patients that have used the affected lot should consult their healthcare provider and they may return the affected lot to their place of purchase.

Jubilant requested wholesalers, distributors, and retailers examine their inventory for the affected lot and quarantine all inventory of the affected lot to prevent further distribution to consumers.

Related topics: Regulatory & Safety, Regulations, QA/QC

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