Wednesday, 25 May 2016 11:28

5% Dextrose Injection Usp In Pab Container Recall- Leakage And Particulate Matter

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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.

Product details

  • 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.
  • Report adverse events or side effects related to the use of this product to NAFDAC office, NAFDAC PRASCOR (20543- 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 126014 times Last modified on Wednesday, 25 May 2016 11:39

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