Table 2 Awareness about FDA announcement on voluntary recall of ranitidine and the issues related
Awareness | Response | All (n = 311) n (%) | Physician (n = 198) n (%) | Pharmacist (n = 113) n (%) | p value |
|---|---|---|---|---|---|
Are you aware of FDA recall notification on ranitidine? | Yes | 230 (74) | 150 (76) | 80 (71) | 0.05 |
No | 81 (26) | 48 (24) | 33 (29) | Â | |
What is the impurity identified? | Yes | 230 (74) | 150 (76) | 80 (71) | 0.05 |
No | 81 (26) | 48 (24) | 33 (29) | Â | |
What is the ADR caused by the impurity? | Yes | 286 (92) | 188 (95) | 98 (87) | 0.05 |
No | 25 (8) | 10 (5) | 15 (13) | Â | |
What is the source of the impurity? | Yes | 40 (13) | 28 (14) | 101 (90) | <0.001 |
No | 271 (87) | 170 (86) | 12 (10) | Â | |
What is the maximum daily intake of the impurity identified? | Yes | 18 (6) | 11 (5) | 7 (6) | 0.992 |
No | 293 (94) | 187 (96) | 106 (94) | Â | |
What is the currently agreed threshold for the impurity in ranitidine? | Yes | 12 (4) | 08 (4) | 04 (3) | 0.992 |
No | 299 (96) | 190 (96) | 109 (97) | Â | |
How do you calculate the limit of the impurity in parts per million? | Yes | 76 (24) | 11 (5) | 65 (58) | <0.001 |
No | 235 (76) | 187 (95) | 48 (42) | Â | |
Do you know the call back impact on Indian manufacturers? | Yes | 114 (37) | 26 (13) | 88 (78) | <0.001 |
No | 197 (63) | 172 (87) | 25 (22) | Â | |
Does the impurity in ranitidine products pose any immediate health risks? | Yes | 300 (96) | 198 (100) | 102 (90) | 0.05 |
No | 11 (4) | 0 | 11 (10) | Â |