Other safety alerts
|
| |
| The United Kingdom: Class 4 Drug Alert (Caution in Use): 8.4% w/v Sodium Bicarbonate - B. Braun Melsungen AG – due to the presence of precipitation |
| |
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) announced that B. Braun Melsungen AG has informed MHRA that during regular visual inspection of retained samples of Sodium Bicarbonate solutions with bromobutyl stoppers precipitation in solution was observed. The particles have been identified as aluminum salt precipitation. A fluctuation in the bromobutyl stopper quality, resulting in the leaching of aluminum compounds is believed to be the cause of the issue. The batches from 120428021 to 131558022 have been released to the UK market using bromobutyl stoppers.
No customer complaints or adverse drug reactions have been received in relation to these observations to date.
Due to concerns with continuity of supply these batches are not being recalled at this time. As a precaution MHRA advise the following actions prior to administration:
- Visually inspect the product prior to use and only use if the product is clear and free from particles.
Ensure that a standard fluid infusion set with integral filter (15 micron) is used for infusion.
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/Publications/Safetywarnings/../CON348292
In Hong Kong, Sodium Bicarbonate 8.4% Infusion (HK-28230) is registered by B Braun Medical (HK) Limited (B Braun). The Department of Health was informed by the company on 3 December 2013 regarding the news. Subsequently a recall of all batches of the product that using the affected stopper was initiated in Hong Kong and press release was issued on the same day.
Ends/ Friday, December 06, 2013
Issued at HKT 12:30
|
| |
|
