Buccolam
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 recall | 2 |
| BASG reference number | INS-640.001-2342 |
Further inquiry note
Page last modified:
12/07/2022