Class 4 Drug Alert (Caution in Use): 8.4% w/v Sodium Bicarbonate - B. Braun Melsungen AG - PL 03551/0069
- Medicines and Healthcare products Regulatory Agency
- 5 December 2013
- Alert type:
- Drug alert
- Medical speciality:
- Critical care and Pharmacy
This alert has been issued as B. Braun Melsungen AG has informed us 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.
CLASS 4 MEDICINES DEFECT INFORMATION
Caution in Use
Distribute to Hospital Pharmacy, Ward and Wholesale Level
|05 December 2013||EL (13)A/27||Our ref: MDR 61-11/13|
Dear Healthcare Professional,
B. Braun Melsungen AG
8.4% w/v Sodium Bicarbonate
|Batch number range from and to inclusive||Expiry date range from and to inclusive||Pack Size||First distributed|
|120428021 to 131558022||December 2013 to March 2015||100ml and 250ml||March 2012|
B. Braun Melsungen AG has informed us 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 above batches have been released to 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 we 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.
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.
Defective Medicines Report Centre
151 Buckingham Palace Road
Telephone +44 (0)20 3080 6574
MHRA Distribution (further recipients by cascade): .
Issued: 5 December 2013
Alert type: Drug alert