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My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levono...

FDA Recall #D-0837-2018 — Class II — May 17, 2018

Recall #D-0837-2018 Date: May 17, 2018 Classification: Class II Status: Terminated

Product Description

My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.

Reason for Recall

Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.

Recalling Firm

Lupin Pharmaceuticals Inc. — Baltimore, MD

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

43,922 cartons

Distribution

Nationwide in the USA

Code Information

Lot #: M16317A1, M16317A4, M16317A5, Exp 11/18

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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