Leader, Major Pharma & Rugby Labs Drug Recall [US]


US FlagUS/Silver Spring: Leader, Major Pharma & Rugby Labs Drug Recall [US]Leader Brand, Major Pharmaceuticals and Rugby Laboratories recalls all Liquid Drug products manufactured by PharmaTech LLC at its FDA-registered facility in Davie, Florida due to possible Burkholderia cepacia (“B. cepacia”) contamination, a serious health hazard. FDA: http://ht.ly/Shu430elrry

Direct link: https://www.fda.gov/Safety/Recalls/ucm571001.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Drugs are subject to this recall:

  • Leader Brand branded drugs
    • Liquid Multivitamin Supplement for Infants and Toddlers, sold in 50 mL bottles with a UPC of 096295128611
    • Liquid Vitamin D Supplement for Breastfed Infants 400 IU, sold in 50 mL bottles with a UPC of 096295128628
  • Major Pharmaceuticals branded drugs
    • Certa-Vite Liquid, sold in 236 mL bottles with a UPC of 00904-5023-09
    • D-Vita Drops, sold in 50 mL bottles with a UPC of 00904-6273-50
    • Ferrous Drops Iron Supp, sold in 50 mL bottles with a UPC of 00904-6060-50
    • Poly-Vita Drops W/Iron, sold in 50 mL bottles with a UPC of 00904-5100-50
    • Poly-Vita Drops, sold in 50 mL bottles with a UPC of 00904-5099-50
    • Senna Syrup, sold in 237 mL bottles with a UPC of 00904-6289-09
    • Tri-Vita Drops, sold in 50 mL bottles with a UPC of 00904-6274-50
  • Rugby Laboratories branded drugs
    • Aller Chlor Syrup, sold in 120 mL bottles with a UPC of 00536-1025-47
    • C Liquid 500mg, sold in 118 mL bottles with a UPC of 00536-0160-97
    • Calcionate Syrup, sold in 16 fluid ounce bottles with a UPC of 00536-2770-85
    • Cerovite Liquid, sold in 236 mL bottles with a UPC of 00536-2790-59
    • D3 400IU Liquid, sold in 50 mL bottles with a UPC of 00536-8400-80
    • Diocto Liquid 50mg/5ml , sold in 473 mL bottles with a UPC of 00536-0590-85
    • Diocto Syrup 60MG/15 mL bottles, sold in 473 mL bottles with a UPC of 00536-1001-85
    • Fer Iron Liquid 50 mL bottles, sold in 50 mL bottles with a UPC of 00536-0710-80
    • Ferrous Sulfate Elixir, sold in 473 mL bottles with a UPC of 00536-0650-85
    • Poly-Vitamin Liquid, sold in 50 mL bottles with a UPC of 00536-8450-80
    • Poly-Vitamin with Iron Liquid, sold in 50 mL bottles with a UPC of 00536-8530-80
    • Senexon Liquid, sold in 237 mL bottles with a UPC of 00536-1000-59
    • Tri-Vitamin Liquid, sold in 50 mL bottles with a UPC of 00536-8501-80

Please consult the photograph above for details of the Drug’s packaging, design and retail presentation. Additional images of the recalled Liquid Drugs can be found on the Web site above.

According to the FDA, Leader Brand, Major Pharmaceuticals, and Rugby Laboratories are jointly issuing a nationwide recall of all lots within expiry of all Liquid Drug products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Florida. due to possible B. cepacia contamination.

The Drugs subject to this recall were distributed US nationwide to wholesale and retail facilities, including hospitals and pharmacies. The distribution firm Rugby Laboratories learned of a potential issue with a product manufactured by PharmaTech LLC, specifically several adverse event reports of B. cepacia infections in patients, which may be linked to PharmaTech-manufactured Diocto Syrup Laxative or Diocto Liquid Laxative. Both of these preparation are based on the generic Docusate Sodium solution.

==> For information about Salmonellosis (Salmonella poisoning), please consult the “Illnesses” tab on this site, located at the top of this page.

==> Never depend on your senses of sight, smell, taste or touch to confirm drug poisoning, adulteration or contamination.

If you believe you have purchased or have in your possession any of the recalled Drugs, please do not consume them directly nor use them as an ingredient in another dish or preparation. Instead, return the Drugs to the store where you purchased it for a full refund.

If you have any questions about this recall, please contact Rugby Laboratories / Major Pharmaceuticals Customer Support at 1-800-645-2158 from 8:00 AM to 8:00 PM Monday through Friday or Leader Customer Support at 1-800-200-6313, option 1, from 8:00 AM to 8:00 PM Monday through Thursday, EST and from 8:00 AM to 5:00 PM on Fridays.

==> To see other recalls and notifications caused by suspected contaminated Laxatives, please search for “laxatives” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Burkholderia cepacia contamination, please search for “Burkholderia” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 9062-2017
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

We welcome your feedback:
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E. & O. E.

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