Recall of diabetes medication over cancer-causing contaminant expanded

by: Haley Townsend and Nexstar Media Wire Posted: Oct 9, 2020 / 12:55 PM CDT…

Recall of diabetes medication over cancer-causing contaminant expanded

Courtesy FDA

(NewsNation Now) — A recall of the commonly prescribed diabetes drug Metformin has expanded over concerns of high levels of a cancer-causing contaminant, the FDA announced earlier this week.

Metformin is used to treat type 2 diabetes and helps to control high blood sugar.

An additional 76 lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, and 750mg may contain levels of a cancer-causing contaminant higher than the acceptable daily intake limit.

Marksans Pharma Limited, India, voluntarily expanded the recall after it was initially issued back in June to include 76 unexpired lots of the medication. Marksans performed tests on the unexpired marked lots and observed levels of N-Nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen or a substance that could cause cancer, in excess of the acceptable Daily Intake Limit (ADI) of 96ng/day.

According to the release from the FDA, “Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.”

The FDA says consumers taking the recalled medication should continue taking it until a doctor or pharmacist gives them a replacement or another treatment option, as it could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional.

The FDA says the following are included in the expanded recall. The lot number can be found on the side panel of bottle labels as well as shipper/case labels.

S.No. Product Name NDC No. Pack Size Lot # Expiry Date
1. Metformin HCL ER Tablets
USP 500 mg
49483-623-50 500 E037F Oct-20
2. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 E072F Oct-20
3. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 E074F Oct-20
4. Metformin HCL ER Tablets
USP 500 mg
49483-623-10 1000 D086F Oct-20
5. Metformin HCL ER Tablets
USP 500 mg
49483-623-50 500 G011F Oct-20
6. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 E076F Oct-20
7. Metformin HCL ER Tablets
USP 500 mg
49483-623-01 100 XP8260 Oct-20
8. Metformin HCL ER Tablets
USP 500 mg
49483-623-10 1000 G012F Nov-20
9. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 D096F Nov-20
10. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 XP8276 Nov-20
11. Metformin HCL ER Tablets
USP 500 mg
49483-623-50 500 F001F Nov-20
12. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 H029F Nov-20
13. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 H031F Nov-20
S.No. Product Name NDC No. Pack Size Lot # Expiry Date
14. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 XP8289 Nov-20
15. Metformin HCL ER Tablets
USP 500 mg
49483-623-50 500 H041F Dec-20
16 Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 L007F Dec-20
17. Metformin HCL ER Tablets
USP 500 mg
49483-623-10 1000 L008F Dec-20
18. Metformin HCL ER Tablets
USP 500 mg
49483-623-50 500 L009F Dec-20
19. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 J022F Dec-20
20. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 H039F Dec-20
21. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 J092F Jan-21
22. Metformin HCL ER Tablets
USP 500 mg
49483-623-10 1000 K042F Feb-21
23. Metformin HCL ER Tablets
USP 500 mg
49483-623-50 500 K051F Jun-21
24 Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 L055F Jun-21
25. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 K079F Jul-21
26. Metformin HCL ER Tablets
USP 500 mg
49483-623-10 1000 M001F Jul-21
27 Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 A002G Aug-21
28. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 A003G Aug-21
S.No. Product Name NDC No. Pack Size Lot # Expiry Date
29. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 A007G Aug-21
30. Metformin HCL ER Tablets
USP 500 mg
49483-623-50 500 A115G Sep-21
31. Metformin HCL ER Tablets
USP 500 mg
49483-623-50 500 A010G Sep-21
32. Metformin HCL ER Tablets
USP 500 mg
49483-623-10 1000 A009G Sep-21
33. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 A49001 Nov-21
34. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 A40001 Dec-21
35. Metformin HCL ER Tablets
USP 500 mg
49483-623-10 1000 A40002 Dec-21
36. Metformin HCL ER Tablets
USP 500 mg
49483-623-01 100 XP0010 Dec-21
37. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 A40003 Dec-21
38. Metformin HCL ER Tablets
USP 500 mg
49483-623-10 1000 A40004 Dec-21
39. Metformin HCL ER Tablets
USP 500 mg
49483-623-01 100 XP0016 Dec-21
40. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 A40005 Dec-21
41. Metformin HCL ER Tablets
USP 500 mg
49483-623-50 500 A40006 Jan-22
42. Metformin HCL ER Tablets
USP 500 mg
49483-623-50 500 A40007 Jan-22
43. Metformin HCL ER Tablets
USP 500 mg
49483-623-50 500 A40008 Jan-22
S.No. Product Name NDC No. Pack Size Lot # Expiry Date
44. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 A40009 Feb-22
45. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 A40010 Mar-22
46. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 XP0036 Mar-22
47. Metformin HCL ER Tablets
USP 500 mg
49483-623-50 500 A40011 Mar-22
48. Metformin HCL ER Tablets
USP 500 mg
49483-623-10 1000 A40012 Mar-22
49. Metformin HCL ER Tablets
USP 500 mg
49483-623-01 100 XP0046 Apr-22
50. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 A40013 Mar-22
51. Metformin HCL ER Tablets
USP 500 mg
49483-623-10 1000 A40014 Apr-22
52. Metformin HCL ER Tablets
USP 500 mg
49483-623-09 90 A40015 Apr-22
53. Metformin HCL ER Tablets
USP 500 mg
49483-623-50 500 A40016 Apr-22
54. Metformin HCL ER Tablets
USP 500 mg
49483-623-10 1000 A40017 Apr-22
55. Metformin HCL ER Tablets
USP 500 mg
49483-623-50 500 A40018 Apr-22
56. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 M125E Oct-20
57. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 D001F Nov-20
58. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 C084F Nov-20
S.No. Product Name NDC No. Pack Size Lot # Expiry Date
59. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 F073F Jan-21
60. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 E063F Jan-21
61. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 F072F Mar-21
62. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 J002F Apr-21
63. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 J087F Apr-21
64. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 K080F Jun-21
65. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 L056F Jun-21
66. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 M046F Jul-21
67. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 9R9001 Oct-21
68. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 9R9002 Nov-21
69. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 9R0001 Dec-21
70. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 9R0002 Dec-21
71. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 9R0003 Mar-22
72. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 XR0016 Mar-22
73. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 9R0004 Mar-22
S.No. Product Name NDC No. Pack Size Lot # Expiry Date
74. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 9R0005 Mar-22
75. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 9R0006 Apr-22
76. Metformin HCL ER Tablets
USP 750 mg
49483-624-01 100 9R0007 Apr-22

Read more from the FDA on the recall.