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Thursday, 31 August 2017 11:10

Recall of Sodium Bicarbonate Injection 8.4% USP

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The National Agency for Food and Drug Administration and Control has been informed  by the U.S. Food and Drug Administration (FDA), that Hospira, Inc., a Pfizer company, voluntarily recalled 42 lots of Sodium Bicarbonate Injection 8.4%, USP, 50 mL vials, 5 lots of Neut (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICIN (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level. The recall was due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis; certain drug intoxications, in poisoning by salicylates or methyl alcohol and in certain hemolytic reactions. Sodium bicarbonate is also indicated in severe diarrhea, which is often accompanied by significant loss of bicarbonate.

Neut (4% sodium bicarbonate additive solution) is indicated for use as an additive to raise the pH of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion.

Quelicin (Succinylcholine Chloride Injection, USP) is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

 Potassium Phosphates Injection, USP is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

Possible Associated Risks

If affected products are administered to patients, there is a reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.

Details of affected Products

Manufacturer’s Address:  Hospira Inc.

                                    275 North Field Drive

                                    Lake Forest, IL 60045

                                    United States.

NDC Lot Numbers Expiration Date Strength Configuration/Count
0409-6625-02 72109EV 12/01/2018 8.40% 50ml 1X25 VL
  72110EV 12/01/2018 8.40% 50ml 1X25 VL
  72112EV 12/01/2018 8.40% 50ml 1X25 VL
  72113EV 12/01/2018 8.40% 50ml 1X25 VL
  72114EV 12/01/2018 8.40% 50ml 1X25 VL
  72120EV 12/01/2018 8.40% 50ml 1X25 VL
  73068EV 01/01/2019 8.40% 50ml 1X25 VL
  73071EV 01/01/2019 8.40% 50ml 1X25 VL
  73072EV 01/01/2019 8.40% 50ml 1X25 VL
  73224EV 01/01/2019 8.40% 50ml 1X25 VL
  73225EV 01/01/2019 8.40% 50ml 1X25 VL
  73230EV 01/01/2019 8.40% 50ml 1X25 VL
  73231EV 01/01/2019 8.40% 50ml 1X25 VL
  73232EV 01/01/2019 8.40% 50ml 1X25 VL
  73233EV 01/01/2019 8.40% 50ml 1X25 VL
  73234EV 01/01/2019 8.40% 50ml 1X25 VL
  73235EV 01/01/2019 8.40% 50ml 1X25 VL
  73236EV 01/01/2019 8.40% 50ml 1X25 VL
  73298EV 01/01/2019 8.40% 50ml 1X25 VL
  74058EV 02/01/2019 8.40% 50ml 1X25 VL
  74104EV 02/01/2019 8.40% 50ml 1X25 VL
  74105EV 02/01/2019 8.40% 50ml 1X25 VL
  74106EV 02/01/2019 8.40% 50ml 1X25 VL
  74107EV 02/01/2019 8.40% 50ml 1X25 VL
  74197EV 02/01/2019 8.40% 50ml 1X25 VL
  74198EV 02/01/2019 8.40% 50ml 1X25 VL
  74199EV 02/01/2019 8.40% 50ml 1X25 VL
  74200EV 02/01/2019 8.40% 50ml 1X25 VL
  74201EV 02/01/2019 8.40% 50ml 1X25 VL
  75171EV 03/01/2019 8.40% 50ml 1X25 VL
  75172EV 03/01/2019 8.40% 50ml 1X25 VL
  75173EV 03/01/2019 8.40% 50ml 1X25 VL
  75174EV 03/01/2019 8.40% 50ml 1X25 VL
  75175EV 03/01/2019 8.40% 50ml 1X25 VL
  75176EV 03/01/2019 8.40% 50ml 1X25 VL
  75177EV 03/01/2019 8.40% 50ml 1X25 VL
  75178EV 03/01/2019 8.40% 50ml 1X25 VL
  75293EV 03/01/2019 8.40% 50ml 1X25 VL
  75418EV 03/01/2019 8.40% 50ml 1X25 VL
  75419EV 03/01/2019 8.40% 50ml 1X25 VL                                             

 

Neut (Sodium Bicarbonate additive solution 4%)

NDC Lot Numbers Expiration Date Strength Configuration/Count
0409-6609-25 75386EV 03/1/2019 4%/5ML 1X25 FTV NOVA PLUS
0409-6609-02 72226EV 12/01/2018 4%/5ML 1X25 FTV
0409-6609-02 72236EV 12/01/2018 4%/5ML 1X25 FTV
0409-6609-02 75382EV 03/01/2019 4%/5ML 1X25 FTV
0409-6609-02 75383EV 03/01/2019 4%/5ML 1X25 FTV
         

 

Succinylcholine Chloride Injection, USP/Quelicin

NDC Lot Numbers Expiration Date Strength Configuration/Count
0409-6629-02 74393EV 05/01/2018 200mg/10ml 1X25 FTV
0409-6629-02 75157EV
75367EV
06/01/2018
06/01/2018
200mg/10ml 1X25 FTV
0409-6629-25 75158EV 06/01/2018 200mg/10ml 1X25 FTV NOVA PLUS
0409-6629-02 75367EV 06/01/2018 200mg/10ml 1X25 FTV

 

Potassium Phosphates Injection, USP

NDC Lot Numbers Expiration Date Strength Configuration/Count
0409-7295-01 74119EV 02/01/2019 45mM 25X15ML
0409-7295-01 74120EV 02/01/2019 45mM 25X15ML
0409-7295-01 74121EV 02/01/2019 45mM 25X15ML
0409-7295-01 74307EV 02/01/2019 45mM 25X15ML
0409-7295-01 75326EV 03/01/2019 45mM 25X15ML
0409-7295-01 75327EV 03/01/2019 45mM 25X15ML
0409-7295-01 75215EV 03/01/2019 45mM 25X15ML

Healthcare providers’ action

  • All healthcare providers in possession of the above mentioned recalled lots of Sodium Bicarbonate Injection 8.4%, Neut, Quelicin and Potassium Phosphate should immediately stop their use and return all affected products to the nearest NAFDAC office for appropriate regulatory action.
  • Healthcare providers and patients should report adverse reactions associated with the use of these product to the nearest NAFDAC office, NAFDAC PRASCOR 920543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC…………Safeguarding the health of the Nation!!!

Read 2039 times Last modified on Thursday, 31 August 2017 11:14