Recall of Wholesale & Retail Liquid Products and Liquid Vitamin Supplements Manufactured by PharmaTech

8-17-2017            Recall of Wholesale and Retail liquid products and liquid vitamin supplements manufactured by PharmaTech

Distribution firms: Leader Brand, Major Pharmaceuticals and Rugby Laboratories, have jointly issued a precautionary nationwide recall on August 3rd, 2017 of all lots of liquid products manufactured by PharmaTech LLC, of Davis, Fl. Due to possible product contamination of Burkholderia cepacia (B. cepacia).  People who may have a weakened or developing immune systems or chronic lung disease like cystic fibrosis are most susceptible to bacterial infection that is often resistant to common antibiotics (CDC, 2016). High risk populations include infants, children, and the elderly, who may be more likely to use liquid products.  

Products subject to recall were distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories to both wholesale and retail facilities, including hospitals and pharmacies. Consumers, pharmacies, and healthcare facilities that have products which include but are not limited to, Diocto Syrup and Dioctor Liquid, should stop using and dispensing product immediately.

Consumers with questions regarding this recall should contact Rugby Laboratories/ Major Pharmaceuticals Customer Support at 1-800-645-2158, Monday through Friday 8 a.m- 8 p.m EST. Or Leader Customer Support at 1-800-200-6313 option #1, Monday through Thursday 8 a.m – 7 p.m and Friday 8 a.m – 5 p.m EST. Consumers can contact their physician or healthcare provider if they have additional questions about this product.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

  • Complete and submit the report Online: fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form fda.gov/MedWatch/getforms.htmor call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

Please see the below list of affected products:

LEADER BRAND

Liquid Multivitamin Supplement for Infants and Toddlers 50 mL,

UPC: 096295128611

ALL LOTS

Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL,

UPC: 096295128628

ALL LOTS

MAJOR PHARMACEUTICALS

Certa-Vite Liquid

236ML

00904-5023-09

ALL LOTS

Poly-Vita Drops

50ML

00904-5099-50

ALL LOTS

Poly-Vita Drops W/Iron

50ML

00904-5100-50;

ALL LOTS

Ferrous Drops Iron Supp

50ML

00904-6060-50

ALL LOTS

D-Vita Drops

50ML

00904-6273-50

ALL LOTS

Tri-Vita Drops

50ML

00904-6274-50

ALL LOTS

Senna Syrup

237ML

00904-6289-09

ALL LOTS

 

RUGBY LABORATORIES

C Liquid 500mg

118ML

00536-0160-97

ALL LOTS

Diocto Liquid 50mg/5ml

473ML

00536-0590-85

ALL LOTS

Ferrous Sulfate Elixir

473ML

00536-0650-85

ALL LOTS

Fer Iron Liquid 50ML

50ML

00536-0710-80

ALL LOTS

Senexon Liquid

237ML

00536-1000-59

ALL LOTS

Diocto Syrup 60MG/15ML

473ML

00536-1001-85

ALL LOTS

Aller Chlor Syrup

120ML

00536-1025-47

ALL LOTS

Calcionate Syrup

16OZ

00536-2770-85

ALL LOTS

Cerovite Liquid

236ML

00536-2790-59

ALL LOTS

D3 400iu Liquid

50ML

00536-8400-80

ALL LOTS

Poly-Vitamin Liquid

50ML

00536-8450-80

ALL LOTS

Tri-Vitamin Liquid

50ML

00536-8501-80

ALL LOTS

Poly-Vitamin W/Iron Liquid

50ML

00536-8530-80

ALL LOTS

 

 

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