Products Recalled in 2019
S/N | Date recall was initiated | Product Name/ Product Category | INN Name (s) | Batch Number(s) | Name of Manufacturer | Reasons for recall |
1 | 02/01/2019 | Fiesta stamina | Condoms | DL1608 | DKT | Failed freedom from holes test |
2 | 02/01/2019 | Fiesta Big Black | Condoms | PL1625 | DKT | Failed thickness test |
3 | 18/01/2019 | Jotonol 500mg | Paracetamol | T00418 | Benmed Pharmaceuticals | The batch failed dissolution test |
4 | 18/01/2019 | Zegra 50mg | Sildenafil | 00-218 | Benmed Pharmaceuticals | The batch failed assay test, dissolution test and uniformity of weight |
5 | 15/02/2019 | Cipcina tablet | Ciprofloxacin | 170520 | Shanxi Xinyitong Pharmaceutical Co. Ltd | Failed assay test |
6 | 18/02/2019 | ABZ tablet | Albendazole | ABX1B83 | Indoco remedies | the batches failed Dissolution test |
7 | 25/02/2019 | Trogyl tablets | Metronidazole | 0418033, 0418034 | Biodeal Laboratories Ltd | Black spots on the tablets |
8 | 25/02/2019 | Silvadine cream 1% | Silver Sulfadiazine | 0618003, 1118099 | Biodeal Laboratories Ltd | Voluntary recall following a PPB notification of market complaint on PQMP |
9 | 24/04/2019 | Levonogets 0.75mg | Levonogestrel | P17G003 | Olive Healthcare, India | The batch failed dissolution test, weight variation and Assay |
10 | 09/05/2019 | Sure lubricated condoms dotted | Condoms | P48045, L48037, P48001,P48001, P48027 | HLL Lifecare, | Out of specification for freedom from holes and quantity of lubricant |
11 | 09/05/2019 | Sure lubricated condoms dotted | Condoms | 17DN754, 17DN052 | Innolatex Thailand Ltd | Out of specification for freedom from holes and quantity of lubricant |
12 | 18/06/2019 | Toramin syrup | Chlorpheniramine | 180626 | Comet Healthcare | Color change |
13 | 03/07/2019 | Wombit tablet | Albendazole | 0218071, 0218072, 0317120, 0717073 | Biodeal Laboratories Ltd | Failed dissolution testing |
14 | 28/08/2019 | Atazor-R | Atazanavir/Ritonavir 300/100MG | EM83045, EM803076 | Emcure Pharmaceuticals Ltd | due to an Out of trend result for Hydroxy ritonavir impurity at 12 month stability time point |
15 | 19/09/2019 | Atazor-R | Atazanavir/Ritonavir 300/100MG | All batches | Emcure Pharmaceuticals Ltd | Product was out of trend at 12 months when stored at 30/75% RH |
16 | 19/09/2019 | Atazor-R | Atazanavir/Ritonavir 300/100MG | EM83045 | Emcure Pharmaceuticals Ltd | Product was Out of trend results at 12 months when stored at 30/75% RH. Recall was specific to 500,000 pack of 30s supplied to NASCOP through KEMSA |
17 | 01/10/2019 | Kemoxyl DT 250mg | Amoxicillin | 69660 | Laboratory and Allied Ltd | The batch failed dissolution test |
18 | 10/11/2019 | Silvamax cream | Chlorhexidine,silver sulfadiazine | 5804914 | Universal Corporation Ltd | The batch reported stability falure for CHX content |
19 | 20/11/2019 | Alben oral suspension | Albendazole | 54517008 | GSK | The batch failed Assay test |