Food, drugs, devices › The Harvard Drug Group
Food recall: Rugby Calcionate Syrup, One Pint (473 mL)
FDA enforcement event 78007 is a food recall by The Harvard Drug Group of Livonia, MI, initiated 2 Aug 2017 and classified Class II, with 17 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 52% of the 599 food enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 28 Apr 2020. Initiation: voluntary: firm initiated. The Harvard Drug Group has 21 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
The Harvard Drug Group, Livonia, MI.
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…"
Distribution
"Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-3515-2017 | Rugby Calcionate Syrup, One Pint (473 mL) | 5,771 units | Class II | Terminated | 20 Sep 2017 |
| F-3516-2017 | Rugby Cerovite Liquid, 8 oz. 236ML | 65,611 units | Class II | Terminated | 20 Sep 2017 |
| F-3517-2017 | Rugby D 3 Vitamin Liquid, 400 IUI/1 mL, 1 and 2/3 oz., 50 mL | 105,628 units | Class II | Terminated | 20 Sep 2017 |
| F-3518-2017 | Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL | 27,011 units | Class II | Terminated | 20 Sep 2017 |
| F-3519-2017 | Rugby Liquid Vitamin C Supplement, 4 oz., 118 mL | 30,782 units | Class II | Terminated | 20 Sep 2017 |
| F-3520-2017 | Rugby Ferrous Sulfate Liquid One Pint, (473 mL) | 34,280 units | Class II | Terminated | 20 Sep 2017 |
| F-3521-2017 | Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL) | 113,829 units | Class II | Terminated | 20 Sep 2017 |
| F-3522-2017 | Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL) | 117,098 units | Class II | Terminated | 20 Sep 2017 |
| F-3523-2017 | Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL) | 52,897 units | Class II | Terminated | 20 Sep 2017 |
| F-3524-2017 | Major CertaVite Liquid, 8 oz. (236 mL) | 61,262 units | Class II | Terminated | 20 Sep 2017 |
| F-3525-2017 | Major D-Vita Drops, 1 2/3 oz (50 mL) | 27,447 units | Class II | Terminated | 20 Sep 2017 |
| F-3526-2017 | Major Ferrous Drops, 1 2/3 oz (50 mL) | 63,005 units | Class II | Terminated | 20 Sep 2017 |
| F-3527-2017 | Major Poly-Vita Drops, 1 2/3 oz (50 mL) | 27,735 units | Class II | Terminated | 20 Sep 2017 |
| F-3528-2017 | Major Poly-Vita Drops with Iron, 1 2/3 oz (50 mL) | 33,390 units | Class II | Terminated | 20 Sep 2017 |
| F-3529-2017 | Major Tri-Vita Drops, 1 2/3 oz (50 mL) | 10,074 units | Class II | Terminated | 20 Sep 2017 |
| F-3530-2017 | Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1 2/3 oz (50 mL) | 3,840 units | Class II | Terminated | 20 Sep 2017 |
| F-3531-2017 | Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL) | 1,728 units | Class II | Terminated | 20 Sep 2017 |
Context
Other enforcement events for The Harvard Drug Group
All 21 events for The Harvard Drug Group
Questions and answers
Why was this food recalled?
FDA's record gives the reason for recall as: "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…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 Apr 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA food enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.