Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:

Recall Reason Description

Due 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 Description

Metformin Hydrochloride for Extended-Release Tablets, USP 500 mg and 700 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 NameNDC No.Pack SizeLot #Expiry Date
1.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500E037FOct-20
2.Metformin HCL ER Tablets
USP 500 mg
49483-623-5090E072FOct-20
3.Metformin HCL ER Tablets
USP 500 mg
49483-623-5090E074FOct-20
4.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000D086FOct-20
5.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500G011FOct-20
6.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990E076FOct-20
7.Metformin HCL ER Tablets
USP 500 mg
49483-623-01100XP8260Oct-20
8.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000G012FNov-20
9.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990D096FNov-20
10.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990XP8276Nov-20
11.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500F001FNov-20
12.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990H029FNov-20
13.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990H031FNov-20

S.No.Product NameNDC No.Pack SizeLot #Expiry Date
14.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990XP8289Nov-20
15.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500H041FDec-20
16Metformin HCL ER Tablets
USP 500 mg
49483-623-0990L007FDec-20
17.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000L008FDec-20
18.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500L009FDec-20
19.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990J022FDec-20
20.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990H039FDec-20
21.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990J092FJan-21
22.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000K042FFeb-21
23.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500K051FJun-21
24Metformin HCL ER Tablets
USP 500 mg
49483-623-0990L055FJun-21
25.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990K079FJul-21
26.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000M001FJul-21
27Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A002GAug-21
28.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A003GAug-21

S.No.Product NameNDC No.Pack SizeLot #Expiry Date
29.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A007GAug-21
30.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A115GSep-21
31.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A010GSep-21
32.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000A009GSep-21
33.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A49001Nov-21
34.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A40001Dec-21
35.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000A40002Dec-21
36.Metformin HCL ER Tablets
USP 500 mg
49483-623-01100XP0010Dec-21
37.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A40003Dec-21
38.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000A40004Dec-21
39.Metformin HCL ER Tablets
USP 500 mg
49483-623-01100XP0016Dec-21
40.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A40005Dec-21
41.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A40006Jan-22
42.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A40007Jan-22
43.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A40008Jan-22

S.No.Product NameNDC No.Pack SizeLot #Expiry Date
44.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A40009Feb-22
45.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A40010Mar-22
46.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990XP0036Mar-22
47.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A40011Mar-22
48.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000A40012Mar-22
49.Metformin HCL ER Tablets
USP 500 mg
49483-623-01100XP0046Apr-22
50.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A40013Mar-22
51.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000A40014Apr-22
52.Metformin HCL ER Tablets
USP 500 mg
49483-623-0990A40015Apr-22
53.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A40016Apr-22
54.Metformin HCL ER Tablets
USP 500 mg
49483-623-101000A40017Apr-22
55.Metformin HCL ER Tablets
USP 500 mg
49483-623-50500A40018Apr-22
56.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100M125EOct-20
57.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100D001FNov-20
58.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100C084FNov-20

S.No.Product NameNDC No.Pack SizeLot #Expiry Date
59.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100F073FJan-21
60.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100E063FJan-21
61.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100F072FMar-21
62.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100J002FApr-21
63.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100J087FApr-21
64.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100K080FJun-21
65.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100L056FJun-21
66.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100M046FJul-21
67.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R9001Oct-21
68.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R9002Nov-21
69.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R0001Dec-21
70.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R0002Dec-21
71.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R0003Mar-22
72.Metformin HCL ER Tablets
USP 750 mg
49483-624-01100XR0016Mar-22
73.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R0004Mar-22

S.No.Product NameNDC No.Pack SizeLot #Expiry Date
74.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R0005Mar-22
75.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R0006Apr-22
76.Metformin HCL ER Tablets
USP 750 mg
49483-624-011009R0007Apr-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 [email protected].

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.

Initial press release


Company Contact Information

Consumers:
Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc.,
631-753-9090; ext. 160
[email protected]

Product Photos