Home / Recalls / Lupin Pharmaceuticals Inc. / D-0837-2018

D-0837-2018 Class II Terminated

Recalled by Lupin Pharmaceuticals Inc. — Baltimore, MD

Recall Details

Product Type
Drugs
Report Date
May 30, 2018
Initiation Date
May 17, 2018
Termination Date
May 1, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
43,922 cartons

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.

Distribution Pattern

Nationwide in the USA

Code Information

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

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