Product Recall: Modified Fluid Gelatin 4% Injection (Infusol SG)

posted Nov 3, 2019, 9:04 PM by Muhammad Fikree Ahmad   [ updated Nov 3, 2019, 9:05 PM ]
24th October 2019 (Circular No. SP PPUM:   447/2019): 


Product Name

:  Modified Fluid Gelatin 4% Injection (Infusol SG)

Dosage Form

:  Injection

Manufacturer

:  Ain Medicare Sdn Bhd

Formulary Category

:  Standard Formulary

Batch Number

:  P390A262

Product Registration Number

:  MAL12085086XZ

Reason for Recall

:  Failure to pass bacterial endotoxin test


Please be informed that Ain Medicare Sdn Bhd, the distributor of this product, has been given notice of product recall for the particular batch number P390A262 due to failure to pass bacterial endotoxin testThe use of this product should be stopped immediately.

Therefore, all clinical areas keeping the stocks for this product are required to do prompt checking on the batch number of the current stocks. Kindly segregate the affected stocks according to the batch number and send to Inpatient Pharmacy for exchange of stocks.