Drug recall D-0837-2018

Class II Terminated reported May 30, 2018

Product

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.

Lots and codes

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

Recall details

Recalling firm
Lupin Pharmaceuticals Inc., Baltimore, MD
Quantity
43,922 cartons
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
May 17, 2018
Terminated
May 1, 2019

Related products