Posted from: Thursday, July 09, 2015 - 02:39 PM - Present

Important Information: Drug Recall

Lutera Recalled

July 7, 2015, The U.S. Food and Drug Administration announced a recall of Lutera (ethinyl estradiol/levonorgestrel) manufactured by Watson/Actavis. The Class III recall was prompted only as a result of incorrect or missing package inserts and no adverse health reactions have been associated with this recall.

The voluntary recall of this birth control impacts 511,283 boxes from the following lots:

KPPY – Expiration date of June 2015

NBXD, NBXF – Expiration date of October 2016

NBXG – Expiration date of September 2015

NKZS – Expiration date of November 2015

NMPT, NNXB, NNWG – Expiration date of January 2016

NMPV, NVWN, NVWP – Expiration date of February 2016

NMTP, NNXC – Expiration date of March 2016

NMWC, NNXH – Expiration date of April 2016

PFHT, PFHW, PFHX – Expiration date of June 2016

PKHH, PKHN, PKHS, PKHT, PPGG, PPGH, PVSZ – Expiration date of August 2016

PYDX – Expiration date of September 2016

For those members that have this product or any questions about the recall, it is suggested that they contact their pharmacy. 

Adverse events that may be related to the use of this product may also be reported to the United States Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

Online: www.fda.gov/medwatch/report.htm

Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm.  Mail the form to: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

Fax: 1-800-FDA-0178

Last Updated Thursday, March 23, 2017 - 08:28 AM.