PlainRecalls
FDA Food Moderate Class II Terminated

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

Reported: September 20, 2017 Initiated: August 2, 2017 #F-3531-2017

Product Description

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

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.

Details

Recalling Firm
The Harvard Drug Group
Units Affected
1,728 units
Distribution
Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305
Location
Livonia, MI

Frequently Asked Questions

What product was recalled?
Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL). Recalled by The Harvard Drug Group. Units affected: 1,728 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Food on September 20, 2017. Severity: Moderate. Recall number: F-3531-2017.