Elevated risk U.S. Food and Drug Administration

Actavis Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg recall: Due to detection of N-Nitrosodimethylamine (NDMA)

Recall published 6+ years ago

Due to detection of N-Nitrosodimethylamine (NDMA)

Actavis Prescription & OTC drugs — recalled prescription & otc drugsActavis Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Actavis Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)Actavis 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

This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

What the notice says: 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
June 2, 2020
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Actavis
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

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

What the company announced

Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI).

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 and found in water and foods, including meats, dairy products, and vegetables.

Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The lots being recalled are packaged under the Actavis Pharma, Inc. label and are contained in the table below. They were distributed nationwide in the USA as retail bottles of 100 tablets and 1000 tablets to Teva’s direct customers between January 8, 2019 and May 27, 2020.

The affected Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, being recalled are described as:

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, white to off-white capsule shaped tablets, debossed with an Andrx logo with “571”on one side and “500” on the opposite side.

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, light yellow capsule shaped tablets, debossed with an Andrx logo with “577” on one side and “750” on the opposite side.

  • NDC: 62037-571-01 · Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count · Lot Number: 1329548A · Expiration: 06/2020
  • NDC: 62037-571-01 · Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count · Lot Number: 1338302M · Expiration: 10/2020
  • NDC: 62037-571-01 · Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count · Lot Number: 1348968M · Expiration: 10/2020
  • NDC: 62037-571-01 · Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count · Lot Number: 1348969M · Expiration: 11/2020
  • NDC: 62037-571-01 · Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count · Lot Number: 1348970M · Expiration: 10/2020
  • NDC: 62037-571-01 · Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count · Lot Number: 1376339M · Expiration: 09/2021
  • NDC: 62037-571-10 · Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count · Lot Number: 1323460M · Expiration: 06/2020
  • NDC: 62037-571-10 · Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count · Lot Number: 1330919M · Expiration: 06/2020
  • NDC: 62037-571-10 · Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count · Lot Number: 1338300A · Expiration: 10/2020
  • NDC: 62037-571-10 · Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count · Lot Number: 1341135M · Expiration: 12/2020
  • NDC: 62037-571-10 · Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count · Lot Number: 1391828M · Expiration: 11/2021
  • NDC: 62037-577-01 · Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count · Lot Number: 1333338M · Expiration: 08/2020
  • NDC: 62037-577-01 · Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count · Lot Number: 1333339A · Expiration: 08/2020
  • NDC: 62037-577-10 · Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 1000 Count · Lot Number: 1354471A · Expiration: 02/2021

Teva is notifying its distributors and customers affected by this recall via FedEx overnight mailing. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US Food & Drug Administration, It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin .

Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Teva products being recalled should contact Teva Medical Information by phone at: 888-838-2872, option 3, then, option 4. Live calls are received Monday-Friday, 9:00 am to 5:00 pm Eastern Time with voicemail available 24 hours/day, 7 days/week or by email at [email protected] .

Patients wishing to return product may contact Teva’s product recall processor to obtain instructions and a return kit for returning their medication:

Contact Inmar at 1-855-532-1850 (Hours of Operation: 9 am to 5 pm Eastern Time, Monday – Friday) or email Inmar at: [email protected] .

Inmar will provide the materials needed to return their medication and instructions for reimbursement.

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.

Patient safety and product quality are critical to Teva. Teva will continue to partner with, and regularly update, all relevant regulatory authorities as relevant information becomes available.

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 36 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 500
  • 750
  • 1329548A
  • 1338302M
  • 1348968M
  • 1348969M
  • 1348970M
  • 1376339M
  • 1323460M
  • 1330919M
  • 1338300A
  • 1341135M
  • 1391828M
  • 1333338M
  • 1333339A
  • 1354471A

Best-by / use-by date

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

  • 06/2020
  • 10/2020
  • 11/2020
  • 09/2021
  • 12/2020
  • 11/2021
  • 08/2020
  • 02/2021

Establishment number

Inside the USDA mark of inspection on the label.

  • 571
  • 500
  • 577
  • 750

NDC number

On the carton and again on the bottle or blister label.

  • 62037-571-01
  • 62037-571-10
  • 62037-577-01
  • 62037-577-10

Package size

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

  • 500 mg
  • 750 mg
  • 1000 count
  • 100 Count

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

Actavis — This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

  1. Stop using the product and keep it away from children and pets.
  2. Do not pour it down a drain or into a bin without checking local hazardous-waste rules, and never mix it with another cleaner.
  3. Ventilate the room if the product was sprayed or applied there.
  4. Keep the container — the lot code on it is what a refund claim and any medical follow-up both depend on.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.

Company contact: Teva Pharmaceuticals USA Inc. — Consumers: Teva’s Medical Information, 888-838-2872, [email protected] — Media: Kelley Dougherty, Eric Rubin, 973-832-2819, 862-221-7151

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 Actavis prescription & otc drugs recalled?

Due to detection of N-Nitrosodimethylamine (NDMA) 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 500, 750, 1329548A; best-by date 06/2020 or 10/2020; establishment number 571, 500. 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?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Where was the recalled product sold?

It was distributed nationwide.

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