Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL)

Recall map → All recalls → F-3531-2017

Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL) The Harvard Drug Group · reported 2017-09-20

Terminated This recall has been closed out by the agency.

Reason for recall: The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
Classification: Class II
Recall initiated: 2017-08-02
Reported by the agency: 2017-09-20
Closed out (terminated): 2020-04-28
Recalling firm: The Harvard Drug Group
Livonia, MI
United States
This is the firm that issued the recall — commonly a distributor or processor. It is not the origin of contamination.
Distribution (the agency's own words): Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305
States we parsed from that text: SC VA
The agency named these states. Parse method explicit_state_list, confidence high.
Food category: Dietary supplementsderived
Assigned by a reviewed keyword rulebook over the product description, not by the agency.
Recall type: Voluntary: Firm initiated
Recall number: F-3531-2017

This page reproduces a record published by the US Food and Drug Administration. It is not real-time: recalls typically appear in FDA's Enforcement Report weeks after they begin — a median of 40 days, see publication lag. For current food safety information consult FDA and USDA FSIS directly.