The Agency has been notified of the recall of one lot of 5% Dextrose injection USP 100/150ml containers manufactured by B. Braun Medical Inc. Dextrose injections are electrolyte elevating fluids intended for intravenous administration. They may also be used as diluents and delivery system for intermittent administration of compatible additive drugs.
Reason for recall
- Leakages of solution containers due to compromise of container integrity
- Presence of particulate matter identified to be microbial growth within the solution
Possible associated risk
Administration of non sterile intravenous products will result in infections that may cause serious adverse health events including septicemia, sepsis, septic shock, organ damage and death.
- Manufacturer: B. Braun Medical Inc
- Product specification: 5% Dextrose Injection USP 100/150ml
- Lot number: J5J706
- NDC: 0264-1510-32
- Catalog No: 55104-5264
- Expiry date: 31/10/2016
Healthcare provider's action
- Stop administration of affected products
- Select and quarantine products affected lot and destroy product according to hospital destruction policy.
NAFDAC…Safeguarding the health of the Nation!!!