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Product Recall: Hydralazine Hydrochloride 20mg/ml injection

posted Feb 25, 2020, 6:00 PM by Rafidah binti Abd Rahim   [ updated Mar 26, 2020, 12:19 AM by Ho Ai Wui ]
21 February 2020 (Circular No. SP PPUM: 51/2020)

Product Name

:

Hydralazine Hydrochloride 20mg/ml injection

Active Ingredient

:

Hydralazine

Strength

:

20mg/ml

Dosage Form

:

Injection

Manufacturer

:

Ciron Drugs & Pharmaceuticals PVT.LTD.India

Formulary Category

:

Standard Formulary

Product Registration Number

:

MAL10053652AZ

Batch Number

:

(i)    8EB04439 , MFG : 11/2018, EXP : 10/2020

(ii)   9EB16157 , MFG : 04/2019, EXP : 03/2021

(iii)  9EB18367 , MFG : 10/2019, EXP : 09/2021


Please be informed that Zulat Pharmacy Sdn. Bhd., the distributor of this product, has issued notice of product recall for the particular batch numbers 8EB04439, 9EB16157, and 9EB18367 due to precipitation found in the affected ampules. The 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.