Elevated risk U.S. Food and Drug Administration

Heritage Losartan Potassium Tablets USP recall: Due to the detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)

Recall published 7+ years ago

Due to the detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)

Heritage Prescription & OTC drugs — recalled prescription & otc drugsHeritage Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Heritage Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)Heritage 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: Potency, impurity or stability failure

This is a specification failure: testing showed the product does not match what the label promises.

What the notice says: Due to the detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

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
May 3, 2019
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Heritage
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Losartan Potassium Tablets USP

What the company announced

Vivimed Life Sciences Pvt Ltd (Vivimed) is recalling 19 lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg to consumer level due to the detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer) that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA cannot be ruled out.

This product is made by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc , East Brunswick NJ (Heritage). To date, neither Vivimed nor Heritage has received any reports of adverse events related to this recall.

Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, nephropathy in Type 2 diabetic patients and is packaged in 90-count and 1000-count bottles. The lots were manufactured by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage) .

The identifying NDC #s associated with Heritage distributed product are as follows:

Losartan Tablets 25 mg: 90- count: NDC 23155-644-09, Losartan Tablets 50 mg: 90- count: NDC 23155-645-09; 1000-count: NDC 23155-645-10, Losartan Tablets 100 mg: 90-count- NDC 23155-646-09 1000-count: NDC 23155-646-10.

The affected Losartan Potassium tablets, includes the 19 lot numbers which are listed below:

  • Product Name: Losartan Potassium Tablets USP, 25 mg · Lot Number: CLO17006A · Pack: 90’s · Expiry Date: Nov 2019 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 50 mg · Lot Number: CLO17007A · Pack: 1000's · Expiry Date: Nov 2019 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 50 mg · Lot Number: CLO17008A · Pack: 1000's · Expiry Date: Nov 2019 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 50 mg · Lot Number: CLO17009A · Pack: 1000's · Expiry Date: Nov 2019 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 50 mg · Lot Number: CLO17009B · Pack: 90's · Expiry Date: Nov 2019 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 50 mg · Lot Number: CLO17010A · Pack: 90's · Expiry Date: Nov 2019 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 100 mg · Lot Number: CLO17012A · Pack: 90's · Expiry Date: Nov 2019 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 100 mg · Lot Number: CLO17013A · Pack: 90's · Expiry Date: Nov 2019 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 100 mg · Lot Number: CLO17014A · Pack: 1000's · Expiry Date: Dec 2019 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 100 mg · Lot Number: CLO17015A · Pack: 1000's · Expiry Date: Jan 2020 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 100 mg · Lot Number: CLO17016A · Pack: 1000's · Expiry Date: Jan 2020 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 100 mg · Lot Number: CLO17017A · Pack: 1000's · Expiry Date: Jan 2020 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 100 mg · Lot Number: CLO18001A · Pack: 1000's · Expiry Date: Jan 2020 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 100 mg · Lot Number: CLO18002A · Pack: 90's · Expiry Date: Jan 2020 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 100 mg · Lot Number: CLO18002B · Pack: 1000's · Expiry Date: Jan 2020 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 100 mg · Lot Number: CLO18020A · Pack: 90's · Expiry Date: Apr 2020 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 100 mg · Lot Number: CLO18021A · Pack: 90's · Expiry Date: Apr 2020 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 100 mg · Lot Number: CLO18022A · Pack: 90's · Expiry Date: Apr 2020 · Distributed by: HERITAGE
  • Product Name: Losartan Potassium Tablets USP, 50 mg · Lot Number: CLO18023A · Pack: 90's · Expiry Date: Apr 2020 · Distributed by: HERITAGE

Losartan Potassium Tablets were distributed Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies.

Inmar is notifying distributors and other customers by recall notification and arranging for return of recalled product of Losartan Potassium Tablets from the above lots.

Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking the product. Pharmacies and healthcare facilities that have the product being recalled from above listed lots should stop using and dispensing the product immediately. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Consumers with questions regarding this recall can contact Vivimed C/o Inmar at 1-877-861-3811 Monday – Friday, 9am – 5pm EST.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, online, by regular mail or by fax.

Complete and submit the report Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

Regular Mail or Fax: Download form https://www.fda.gov/safety/medical-product-safety-information/medwatch-safety-alerts-human-medical-products 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.

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 37 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.

  • 50
  • 100
  • CLO17006A
  • CLO17007A
  • CLO17008A
  • CLO17009A
  • CLO17009B
  • CLO17010A
  • CLO17012A
  • CLO17013A
  • CLO17014A
  • CLO17015A
  • CLO17016A
  • CLO17017A
  • CLO18001A
  • CLO18002A
  • CLO18002B
  • CLO18020A
  • CLO18021A
  • CLO18022A

Best-by / use-by date

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

  • Nov 2019
  • Dec 2019
  • Jan 2020
  • Apr 2020

NDC number

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

  • 23155-644-09
  • 23155-645-09
  • 23155-645-10
  • 23155-646-09
  • 23155-646-10

Model or item number

On the rating label, the box or the instruction sheet.

  • 25
  • 50
  • 100

Package size

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

  • 25 mg
  • 50 mg
  • 100 mg
  • 90 count
  • 1000 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 Potency

Heritage — This is a specification failure: testing showed the product does not match what the label promises.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Call your prescriber or pharmacist and ask whether to swap the lot, re-test, or change nothing.
  3. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.
  4. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Vivimed — Consumers: Vivimed Life Sciences Pvt Ltd, 1-877-861-3811, [email protected] — Media: Mr. Jack Patterson, 1-877-861-3811, [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 Heritage prescription & otc drugs recalled?

Due to the detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) Due to the detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 50, 100, CLO17006A; best-by date Nov 2019 or Dec 2019; model number 25, 50, 100. 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?

Check the lot number on your pack against the codes listed above before you do anything else.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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