FDA MedWatch - GNC Women’s Ultra Mega Time Release 180 count Dietary Supplement by Nutra Manufacturing: Recall - Undeclared Milk

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

GNC Women’s Ultra Mega Time Release 180 count Dietary Supplement by Nutra Manufacturing: Recall - Undeclared Milk

AUDIENCE: Consumer

ISSUE: Nutra Manufacturing, Inc. announced a nationwide, voluntary recall of one lot of GNC Women’s Ultra Mega Time Release dietary supplement product sold in 180 count containers UPC 048107158910, lot number 3044FQ2024, with an expiration date of June 2018 due to the fact the product may contain an undeclared major food allergen, milk. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product.

The affected product was distributed starting in August 23, 2016 through the present and is packaged in an HDPE plastic bottle with a child resistant closure. See the press release for a picture of the product box.

BACKGROUND: The lot number is found on the bottom of the product box and the side panel of the product label.

RECOMMENDATION: If you are in possession of a bottle of GNC Women’s Ultra Mega Time Release180 count, please check the lot number on the product label and do not consume the product if it contains the 3044FQ2024 lot number. Instead, return the product to the GNC retail location where it was purchased for a full refund. If you have any questions concerning this recall, please call GNC Customer Service, which is open weekdays from 8:00 am – 8:30pm EST, at 1-888-462-2548.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm529928.htm