Elevated risk U.S. Food and Drug Administration

Time-Cap Labs Metformin Hydrochloride for Extended-Release Tablets recall: Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Recall published 6+ years ago

Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Time-Cap Labs Prescription & OTC drugs — recalled prescription & otc drugsTime-Cap Labs Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Time-Cap Labs Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)Time-Cap Labs Prescription & OTC drugs — recalled prescription & otc drugs (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Harmful chemical exposure

The hazard here is chemical rather than mechanical, so the right response is to stop using the product and to ventilate or clean anywhere it has been applied.

What the notice says: Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

Why it matters: A chemical that should not be present at this level was found in the product. Depending on the substance, the concern may be a burn or irritation on contact, or a long-term risk from repeated exposure.

Symptoms and when to call a doctor

For a splash or spill, rinse the skin or eyes with running water for 15 to 20 minutes and remove contaminated clothing. If the product was swallowed, or if there is any trouble breathing, call Poison Control on 1-800-222-1222, which operates free and around the clock — or 911 if the person is collapsing, struggling to breathe or unconscious. Take the container or a photo of the label with you to any appointment.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
October 2, 2020
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Time-Cap Labs
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Metformin Hydrochloride for Extended-Release Tablets, USP 500 mg and 750 mg

What the company announced

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

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 44 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • USP 500mg
  • E037F
  • E072F
  • E074F
  • D086F
  • G011F
  • E076F
  • XP8260
  • G012F
  • D096F
  • XP8276
  • F001F
  • H029F
  • H031F
  • XP8289
  • H041F
  • L007F
  • L008F
  • L009F
  • J022F

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • Oct-20
  • Nov-20
  • Dec-20
  • Jan-21
  • Feb-21
  • Jun-21
  • Jul-21
  • Aug-21
  • Sep-21
  • Nov-21
  • Dec-21
  • Jan-22
  • Feb-22
  • Mar-22
  • Apr-22
  • Mar-21
  • Apr-21
  • Oct-21

Package size

Match the net weight or the piece count on the front of the pack.

  • 500 mg
  • 750 mg
  • 90 counts
  • 100 counts
  • 500 counts
  • 1000 counts

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Chemical

Time-Cap Labs — The hazard here is chemical rather than mechanical, so the right response is to stop using the product and to ventilate or clean anywhere it has been applied.

  1. Stop using the product and keep it away from children and pets.
  2. Keep the container — the lot code on it is what a refund claim and any medical follow-up both depend on.
  3. If anyone has symptoms, call Poison Control on 1-800-222-1222 rather than guessing.
  4. Do not pour it down a drain or into a bin without checking local hazardous-waste rules, and never mix it with another cleaner.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Give it ten working days, then chase in writing and quote your claim reference.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.

Remedy named in the notice: 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.

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

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Time-Cap Labs prescription & otc drugs recalled?

Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code USP 500mg, E037F, E072F; best-by date Oct-20 or Nov-20. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the product and keep it away from children and pets.

Can I get my money back?

The notice says: 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.

Where was the recalled product sold?

It was distributed nationwide.

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