Elevated risk U.S. Food and Drug Administration

Bayshore Pharmaceuticals Metformin Hydrochloride Extended-Release Tablets USP recall: Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Recall published 6+ years ago

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

Bayshore Pharmaceuticals Prescription & OTC drugs — recalled prescription & otc drugsBayshore Pharmaceuticals Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 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
August 19, 2020
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Bayshore Pharmaceuticals
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

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

What the company announced

Bayshore Pharmaceuticals, LLC, Short Hills, NJ is voluntarily recalling one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, 1000 count bottles and one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 count bottles within expiry to the consumer level due to the detection of N-Nitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit. This product was manufactured by Beximco Pharmaceuticals Limited, Dhaka, Bangladesh in June 2019, for U.S. distribution by Bayshore.

Bayshore was notified by the U.S. Food and Drug Administration (US FDA) that one lot (Lot number 18657) of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) and recommended recall of the one tested lot.

Bayshore has agreed to recall this lot, and out of an abundance of caution, the company has tested samples from eight (8) lots of Metformin Hydrochloride Extended-Release Tablets manufactured using same API lot of the failed lot. Out of eight (8) lots, one lot (Lot number 18657) of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg and one lot (Lot number 18641) of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg have showed N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI). Hence, Bayshore has decided to recall the two lots (Lot number 18641 and 18657). To date, neither Bayshore nor Beximco have received any reports of adverse events related to use of the product.

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

Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of 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 FDA, it could be dangerous for patients with this serious condition to stop taking their Metformin without first talking to their healthcare 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 .

The Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg lots subject to the recall are identified in the table below.

  • Product Name: Metformin Hydrochloride Extended-Release Tablets USP, 500 mg · Strength: 500 mg · Pack Size: 1000’s Bottle · NDC Number: 76385-128-10 · Lot Number: 18641 · Expiration: MAY 2021
  • Product Name: Metformin Hydrochloride Extended-Release Tablets USP, 750 mg · Strength: 750 mg · Pack Size: 100’s Bottle · NDC Number: 76385-129-01 · Lot Number: 18657 · Expiration: MAY 2021

The affected Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 750 mg, lots were distributed nationwide in the USA by Bayshore directly to Wholesalers and Distributors. Bayshore Pharmaceuticals, LLC is in the process of notifying its customers affected by this recall by phone and through recall notification and is arranging for return of the entire recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the products being recalled should contact Bayshore Pharmaceuticals LLC Information by phone at: 877-372-6093.

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

Contact Qualanex at 888-504-2013

Qualanex 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

Patient safety and product quality are critical to Bayshore. Bayshore 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 12 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.

  • 500
  • 1000
  • 750
  • 100
  • 18657
  • 18641
  • USP 500

Best-by / use-by date

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

  • MAY 2021

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

Bayshore Pharmaceuticals — 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.

Company contact: Bayshore Pharmaceuticals, LLC — Consumers: Qualanex, Bayshore Pharmaceuticals LLC Information, 888-504-2013, 877-372-6093

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 Bayshore Pharmaceuticals 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 500, 1000, 750; best-by date MAY 2021. 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?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide.

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