DDA Drug Recall Notice: Substandard Batches of Calcifer Drops Identified
DDA Drug Recall Notice: Substandard Batches of Calcifer Drops Identified
This notice is published for the information of the concerned manufacturers and their representatives stating that, during market surveillance conducted by this Department, samples of medicines collected were tested at the National Medicines Laboratory. It was found that the medicines produced by the manufacturer mentioned below, bearing the batch number listed in the annex, were of substandard quality. Therefore, in accordance with Section 14 of the Drug Act, 2035 (1978 AD), the sale and distribution of these batch numbers have been prohibited. The concerned parties are instructed to immediately recall these batches from the market and submit the details to this Department. Furthermore, all concerned are requested not to recommend, sell, distribute, or use these batch-numbered medicines.
| S.N. | Name of Medicine | Batch No. | Mfg./Exp. Date | Reason | Manufacturer’s Name and Address |
|---|---|---|---|---|---|
| 1. | CALCIFER DROPS (Cholecalciferol Oral Solution) Each ml contains: Cholecalciferol IP 400 IU | CLLF23012 | Mfg. Date: 08 Oct 2023 Exp. Date: 07 Oct 2025 | Does not comply as per NML AMV Analytical profile No. Chole.D 078/079AP102 with respect to assay test | Manufacturer: National Healthcare Pvt. Ltd., Chhatapipra, Bara, Nepal |
| 2. | CALCIFER DROPS (Cholecalciferol Oral Solution) Each ml contains: Cholecalciferol IP 400 IU | CLLF23014 | Mfg. Date: 05 Nov 2023 Exp. Date: 04 Nov 2025 | Does not comply as per NML AMV Analytical profile No. Chole.D 078/079AP102 with respect to assay test | Manufacturer: National Healthcare Pvt. Ltd., Chhatapipra, Bara, Nepal |
- DDA Drug Recall Notice | Substandard Injections Recalled
- Maturity Level of National Regulatory Authority – DDA Nepal
