All batches of Marcain Polyamp Steripack 0.5% (bupivacaine hydrochloride) - error on carton and ampoule label about administration
(AstraZeneca UK Limited) This presentation cannot be administered by intra-articular means as it states on the carton and ampoule label on all batches released since December 2012 (EL(15)A/09)
29 October 2015
Class 4 caution in use
Hospital and clinic level
MDR 58-08/15
Product details
AstraZeneca UK Limited
Marcain Polyamp Steripack 0.5% (Bupivacaine Hydrochloride)
PL 17901/0145
Alert details
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.
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