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 |
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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 |