Major Ferrous Drops, 1 2/3 oz (50 mL)

FDA recall notice · announced September 20, 2017 · The Harvard Drug Group

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305
Lot/code information: Major Ferrous Drops,1 2/3 oz (50 mL), UPC Number:3 09046 27350 9, All Unexpired Lots
Quantity: 63,005 units
Status: Terminated
Products in this recall event:
- Major CertaVite Liquid, 8 oz. (236 mL) (F-3524-2017)
- Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL) (F-3523-2017)
- Major Poly-Vita Drops, 1 2/3 oz (50 mL) (F-3527-2017)
- Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL (F-3518-2017)
- Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1 2/3 oz (50 mL) (F-3530-2017)
- Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL) (F-3522-2017)
- Rugby Calcionate Syrup, One Pint (473 mL) (F-3515-2017)
- Major Poly-Vita Drops with Iron, 1 2/3 oz (50 mL) (F-3528-2017)
- Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL) (F-3531-2017)
- Major D-Vita Drops, 1 2/3 oz (50 mL) (F-3525-2017)
- Rugby Ferrous Sulfate Liquid One Pint, (473 mL) (F-3520-2017)
- Rugby Liquid Vitamin C Supplement, 4 oz., 118 mL (F-3519-2017)
- Rugby Cerovite Liquid, 8 oz. 236ML (F-3516-2017)
- Major Tri-Vita Drops, 1 2/3 oz (50 mL) (F-3529-2017)
- Rugby D 3 Vitamin Liquid, 400 IUI/1 mL, 1 and 2/3 oz., 50 mL (F-3517-2017)
- Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL) (F-3521-2017)
- Major Ferrous Drops, 1 2/3 oz (50 mL) (F-3526-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.