COMPANY ANNOUNCEMENT
Marksans Pharma Limited Issues Expansion of Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)
This recall has been completed and FDA has terminated this recall.
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason DescriptionDue to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
- Company Name:
- Marksans Pharma Limited
- Brand Name:
-
Brand Name(s)Time-Cap Labs Inc.
- Product Description:
-
Product DescriptionMetformin Hydrochloride for Extended-Release Tablets, USP 500 mg and 750 mg
Company Announcement
Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled.
Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables. Marksans Pharma Limited has not received any reports of adverse events that have been related to this recall.
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 and is packaged in HDPE bottles with the following NDC#s in different packing configurations-
Metformin Hydrochloride Extended-Release Tablets, USP 500mg:
90 counts: 49483-623-09
100 counts: 49483-623-01
500 counts: 49483-623-50
1000 counts: 49483-623-10
Metformin Hydrochloride Extended-Release Tablets, USP 750mg:
100 counts: 49483-624-01
The affected Metformin Hydrochloride Extended-Release Tablets, USP 500mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side and Metformin Hydrochloride Extended-Release Tablets, USP 750mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘102’ on one side and plain on the other side.
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 |
Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750 mg were distributed by Time-Cap Labs, Inc. (located at 7 Michael Avenue, Farmingdale, New York 11735) nationwide in the USA to wholesalers who further distributed to pharmacies.
Marksans Pharma Limited is notifying its distributors and customers by issuing notification letter and press release and is arranging for return/replacement etc. of recalled product lots. Distributors //customers that have affected lots of Metformin Hydrochloride Extended- Release Tablets, USP 500mg & 750mg those are being recalled should return to place of purchase. The lot # can be located on the side panel of bottle labels as well as shipper/case labels.
Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc., located at 7 Michael Avenue, Farmingdale, New York 11735, by phone number 631-753-9090; ext. 160, [Monday to Friday 8am-5pm EST] or e-mail address imcgregor@timecaplabs.com.
Consumers taking these recalled product lots of Metformin ER Tablets should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional. Consumer should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
- Consumers:
- Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc.,
- 631-753-9090; ext. 160
- imcgregor@timecaplabs.com