Calmolan
Replacement
|
Medicines
|
21/03/2014
The marketing authorization holder informed its supplied customers in a letter dated March 20, 2014, that isolated blisters of Calmolan 0.18 mg (packs of 30 / 3 blisters) may have been incorrectly packaged and labeled with an outer label of Calmolan 0.35 mg. Thus, there is a possibility that packages labeled Calmolan 0.35 mg and lot numbers BM831001 or BM831003 are in circulation but contain blisters of 0.18 mg tablets. A stock check should be performed and, if necessary, incorrect packs should be returned directly to G.L. Pharma GmbH.
| Name of the medicinal product | Calmolan 0,35 mg - Tabletten |
|---|---|
| Marketing authorisation number(s) | 1-30128 |
| Marketing authorisation holder | G.L. Pharma GmbH |
| Batch number(s) | BM831001, BM831003 |
| Classification of the recall | 2 |
| BASG reference number | INS - 640.001 - 1059 |
Further inquiry note
Page last modified:
12/07/2022