29 October 2015
Class 4 caution in use
Hospital and clinic level
AstraZeneca UK Limited
Marcain Polyamp Steripack 0.5% (Bupivacaine Hydrochloride)
AstraZeneca has notified us of an error on the carton and ampoule label of all batches of Marcain Polyamps 0.5% released to the UK market since December 2012. The text on the carton and label states that this product may be administered by intra-articular administration. This route of administration is not appropriate for the 0.5% presentation, however. The correct information is presented in the summary of product characteristics (SPC) for Marcain Polyamps.
To ensure continuity of supply, distribution of affected stock will continue whilst the error is being corrected. Corrected stock is expected to be available for distribution by the end of January 2016.
For further information on this matter, contact AstraZeneca for medical information by telephone on 01582 836836
Recipients of this drug alert should bring it to the attention of relevant contacts by copy of the letter below.
Marcain Polyamp Steripack 0.5% - drug alert EL (15)A/09 - letter
Published 29 October 2015