FDA Recall United States TerminatedTerminated: April 28, 2020Historical recordClass II
The Harvard Drug Group
- Product
- Leader Liquid Vitamin D Supplement for Breastfed Infants, 1…
- Published
- September 20, 2017
- Distribution
- Nationwide
The Harvard Drug Group 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. - F-3520-2017
United States
TerminatedClass II
- Company
- The Harvard Drug Group
- Product
- Rugby Ferrous Sulfate Liquid One Pint, (473 mL)
- Recall date
- August 2, 2017
- Terminated
- April 28, 2020
- Source
- FDA
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.
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| Rugby Ferrous Sulfate Liquid One Pint, (473 mL) | Not published in this source record | 34,280 units | Rugby Ferrous Sulfate Liquid,One Pint (473 mL), UPC Number:0 05360 65085 8, All Unexpired Lots |
Distribution
- Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038
- Ph. 303-339-4305
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- F-3520-2017
- Event ID
- 78007
- Status
- Terminated
- Classification
- Class II
- Company
- The Harvard Drug Group
- Product description
- Rugby Ferrous Sulfate Liquid One Pint, (473 mL)
- Quantity
- 34,280 units
- Reason
- 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.
- Recall initiation date
- August 2, 2017
- Report date
- September 20, 2017
- Classification date
- Not published in this source record
- Termination date
- April 28, 2020
- Distribution pattern
- Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305
- UPC, lot, and code information
- Rugby Ferrous Sulfate Liquid,One Pint (473 mL), UPC Number:0 05360 65085 8, All Unexpired Lots
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Press Release
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Other products recalled under this same event
This recall shares FDA event ID 78007 with 10 other product entries in Public Health Trace.
FDA Recall United States TerminatedTerminated: April 28, 2020Historical recordClass II
The Harvard Drug Group
- Product
- Leader Liquid Multivitamin Supplement for Infants and Toddle…
- Published
- September 20, 2017
- Distribution
- Nationwide
FDA Recall United States TerminatedTerminated: April 28, 2020Historical recordClass II
The Harvard Drug Group
- Product
- Major Tri-Vita Drops, 1 2/3 oz (50 mL)
- Published
- September 20, 2017
- Distribution
- Nationwide
FDA Recall United States TerminatedTerminated: April 28, 2020Historical recordClass II
The Harvard Drug Group
- Product
- Major Poly-Vita Drops with Iron, 1 2/3 oz (50 mL)
- Published
- September 20, 2017
- Distribution
- Nationwide
FDA Recall United States TerminatedTerminated: April 28, 2020Historical recordClass II
The Harvard Drug Group
- Product
- Major Poly-Vita Drops, 1 2/3 oz (50 mL)
- Published
- September 20, 2017
- Distribution
- Nationwide
FDA Recall United States TerminatedTerminated: April 28, 2020Historical recordClass II
The Harvard Drug Group
- Product
- Major Ferrous Drops, 1 2/3 oz (50 mL)
- Published
- September 20, 2017
- Distribution
- Nationwide
FDA Recall United States TerminatedTerminated: April 28, 2020Historical recordClass II
The Harvard Drug Group
- Product
- Major D-Vita Drops, 1 2/3 oz (50 mL)
- Published
- September 20, 2017
- Distribution
- Nationwide
FDA Recall United States TerminatedTerminated: April 28, 2020Historical recordClass II
The Harvard Drug Group
- Product
- Major CertaVite Liquid, 8 oz. (236 mL)
- Published
- September 20, 2017
- Distribution
- Nationwide
FDA Recall United States TerminatedTerminated: April 28, 2020Historical recordClass II
The Harvard Drug Group
- Product
- Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL)
- Published
- September 20, 2017
- Distribution
- Nationwide
FDA Recall United States TerminatedTerminated: April 28, 2020Historical recordClass II
The Harvard Drug Group
- Product
- Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL)
- Published
- September 20, 2017
- Distribution
- Nationwide
Responsible company: The Harvard Drug Group
Other recalls from The Harvard Drug Group
FDA Recall TerminatedTerminated: April 30, 2024Historical recordClass II
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61
- Published
- July 5, 2023
- Distribution
- Nationwide
FDA Recall TerminatedTerminated: April 30, 2024Historical recordClass III
Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61
- Published
- May 17, 2023
- Distribution
- Nationwide
FDA Recall TerminatedTerminated: April 30, 2024Historical recordClass II
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: Major Pharmaceuticals Indianapolis, IN 46268 USA. NDC 0904-7257-61, UPC 3 09047 25761 4
- Published
- March 8, 2023
- Distribution
- Nationwide
A map highlighting the states named in the source's distribution description.
Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.
| State | Distributed |
|---|---|
| Virginia | 1 |
| South Carolina | 1 |
States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.
Where this information comes from
View FDA enforcement record -- the specific openFDA record this summary was built from.
This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information. See FDA Enforcement Reports versus recall announcements for how that database differs from a press-release-style announcement.
New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.
Technical source data
View raw source data -- the machine-readable record this page's information was built from.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class II mean?
FDA classifies this recall as Class II. See how to read an FDA recall record (linked above) for what each classification level means.
Is this recall still active?
According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this product?
Follow the responsible agency's published instructions, linked below -- recall guidance is set by that agency, not by Public Health Trace.
Official guidance and record verification
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How to interpret this historical record
This record is preserved as published by FDA, as of April 28, 2020.
Status as reported: Terminated.
This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.
This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.