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