Recall | Medicines | 07/02/2018

The marketing authorization holder has informed its supplied customers in a letter dated 06.02.2018 that the translucent white cap on the tip of the BUCCOLAM application syringe can get stuck. This creates the possibility that administration may be delayed or the cap may accidentally enter the patient's mouth. For this reason, the affected batches are being recalled as a precautionary measure.

Name of the medicinal product BUCCOLAM 2.5 mg, 5 mg, 7.5 mg, 10 mg
Marketing authorisation number(s) EU/1/11/709/001-004
Marketing authorisation holder Shire Services BVBA
Batch number(s) BUCCOLAM 2.5 mg: 1611015, 1702038, 1705029
BUCCOLAM 5 mg: 1612018, 1703013, 1705026
BUCCOLAM 7.5 mg: 1612020, 1702028, 1705015
BUCCOLAM 10 mg: 1612040, 1702033, 1705021, 5707015
Classification of the recall2
BASG reference number INS-640.001-2342

Further inquiry note