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ALERT!!! DRUG RECALL OF SODIUM BICARBONATE INJECTION 8.4% USP

Recall of Sodium Bicarbonate Injection 8.4% USP

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.

NDCLot NumbersExpiration DateStrengthConfiguration/Count
0409-6625-0272109EV12/01/20188.40% 50ml1X25 VL
72110EV12/01/20188.40% 50ml1X25 VL
72112EV12/01/20188.40% 50ml1X25 VL
72113EV12/01/20188.40% 50ml1X25 VL
72114EV12/01/20188.40% 50ml1X25 VL
72120EV12/01/20188.40% 50ml1X25 VL
73068EV01/01/20198.40% 50ml1X25 VL
73071EV01/01/20198.40% 50ml1X25 VL
73072EV01/01/20198.40% 50ml1X25 VL
73224EV01/01/20198.40% 50ml1X25 VL
73225EV01/01/20198.40% 50ml1X25 VL
73230EV01/01/20198.40% 50ml1X25 VL
73231EV01/01/20198.40% 50ml1X25 VL
73232EV01/01/20198.40% 50ml1X25 VL
73233EV01/01/20198.40% 50ml1X25 VL
73234EV01/01/20198.40% 50ml1X25 VL
73235EV01/01/20198.40% 50ml1X25 VL
73236EV01/01/20198.40% 50ml1X25 VL
73298EV01/01/20198.40% 50ml1X25 VL
74058EV02/01/20198.40% 50ml1X25 VL
74104EV02/01/20198.40% 50ml1X25 VL
74105EV02/01/20198.40% 50ml1X25 VL
74106EV02/01/20198.40% 50ml1X25 VL
74107EV02/01/20198.40% 50ml1X25 VL
74197EV02/01/20198.40% 50ml1X25 VL
74198EV02/01/20198.40% 50ml1X25 VL
74199EV02/01/20198.40% 50ml1X25 VL
74200EV02/01/20198.40% 50ml1X25 VL
74201EV02/01/20198.40% 50ml1X25 VL
75171EV03/01/20198.40% 50ml1X25 VL
75172EV03/01/20198.40% 50ml1X25 VL
75173EV03/01/20198.40% 50ml1X25 VL
75174EV03/01/20198.40% 50ml1X25 VL
75175EV03/01/20198.40% 50ml1X25 VL
75176EV03/01/20198.40% 50ml1X25 VL
75177EV03/01/20198.40% 50ml1X25 VL
75178EV03/01/20198.40% 50ml1X25 VL
75293EV03/01/20198.40% 50ml1X25 VL
75418EV03/01/20198.40% 50ml1X25 VL
75419EV03/01/20198.40% 50ml1X25 VL

 

Neut (Sodium Bicarbonate additive solution 4%)

NDCLot NumbersExpiration DateStrengthConfiguration/Count
0409-6609-2575386EV03/1/20194%/5ML1X25 FTV NOVA PLUS
0409-6609-0272226EV12/01/20184%/5ML1X25 FTV
0409-6609-0272236EV12/01/20184%/5ML1X25 FTV
0409-6609-0275382EV03/01/20194%/5ML1X25 FTV
0409-6609-0275383EV03/01/20194%/5ML1X25 FTV

 

Succinylcholine Chloride Injection, USP/Quelicin

NDCLot NumbersExpiration DateStrengthConfiguration/Count
0409-6629-0274393EV05/01/2018200mg/10ml1X25 FTV
0409-6629-0275157EV
75367EV
06/01/2018
06/01/2018
200mg/10ml1X25 FTV
0409-6629-2575158EV06/01/2018200mg/10ml1X25 FTV NOVA PLUS
0409-6629-0275367EV06/01/2018200mg/10ml1X25 FTV

 

Potassium Phosphates Injection, USP

NDCLot NumbersExpiration DateStrengthConfiguration/Count
0409-7295-0174119EV02/01/201945mM25X15ML
0409-7295-0174120EV02/01/201945mM25X15ML
0409-7295-0174121EV02/01/201945mM25X15ML
0409-7295-0174307EV02/01/201945mM25X15ML
0409-7295-0175326EV03/01/201945mM25X15ML
0409-7295-0175327EV03/01/201945mM25X15ML
0409-7295-0175215EV03/01/201945mM25X15ML

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
  • pharmacovigilance@nafdac.gov.ng

Source: NAFDAC

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