|
2020 |
|||||
|
Date |
Product |
Manufacturer |
Market authorization holder |
batch /batches |
Remark |
|
15.12.2020 |
Warfarin Tablets BP (All strength) |
Centurion remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, India |
Yaden International Pvt Ltd |
All batches |
The product withdrawal decision was revoked by the Medicines Evaluation Committee |
|
2021 |
|||||
|
Date |
Product |
Manufacturer |
Market authorization holder |
batch /batches |
Remark |
|
23.08.2021 |
Bupivacaine HCl in Dextrose Inj USP 5mg/80mg |
Ciron drugs and pharmaceuticals Pvt Ltd,N-118, 119, 113, 119/1, 119/2 &118/1, MIDC, Tarapur, Boisar, Dist.Palghar-401506, India |
Ceyoka Pvt Ltd |
0EB02119 |
batch withholding decision on was revoked based on NMQAL recommendation |
|
10.12.2021 |
Low Calcium (2.5mEq/L) Peritonial Dislysis Solution with Dextrose 1.5%w/v (Peritone) |
Peritone Health Sdn.Bhd, Lot 12, Industrial Zone 4, Kulim Hi-Tech Park, Kedah, Malaysia |
Infuxion Lanka Pvt Ltd |
L10182 L10205C1 L10205C2 |
Batch withholding decision was revoked based on the NMQAL recommendation on 10.12.2021. the decision was changed to discontinue to use containers which show the defect (Leakage) |
|
10.12.2021 |
Low Calcium (2.5mEq/L) Peritonial Dislysis Solution with Dextrose 2.5%w/v |
Peritone Health Sdn.Bhd, Lot 12, Industrial Zone 4, Kulim Hi-Tech Park, Kedah, Malaysia |
Infuxion Lanka Pvt Ltd |
L10202 |
Batch withholding decision was revoked based on the NMQAL recommendation on 10.12.2021. the decision was changed to discontinue to use containers which show the defect (Leakage) |
|
22.11.2021 |
PEG+ Electrolytes Powder for Oral Solution 69g (Klean Prep) |
Helsinn Birex Pharmaceuticals Ltd, Damastown, Mulhuddrt, Dublin 15, Ireland |
Hemas Pharmaceutical Pvt Ltd |
All batches |
The committee met on 22.11.2021 recommended to revoke the product withdrawal decision and initiate withdrawal of affected batches and batches expired in 2022. |
|
2022 |
|||||
|
Date |
Product |
Manufacturer |
Market authorization holder |
batch /batches |
Remark |
|
15.11.2022 |
Amoxicillin Capsules BP 500mg |
SPMC, Sri Lanka |
HLF02, HLH25 |
batch withdrawal decision was revoked based on NMQAL recommendation |
|
|
2023 |
|||||
|
Date |
Product |
Manufacturer |
Market authorization holder |
batch /batches |
Remark |
|
03.05.2023 |
Metoprolol Tartrate Tablets BP 50mg |
Centurion remedies Pvt Ltd, G/5 and G/6, Industrial Estate Gorwa, Vadodara-390016, Gujarat, India |
Yaden International Pvt Ltd |
TM-190026 |
batch withholding decision was revoked based on NMQAL recommendation |