Elevated risk U.S. Food and Drug Administration

GSMS Losartan potassium tablets recall: Detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)

Recall published 7+ years ago

Detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)

GSMS Prescription & OTC drugs — recalled prescription & otc drugsGSMS Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)GSMS Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)
3 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: Detection of an impurity – 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
June 10, 2019
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
GSMS
Product type
Prescription & OTC drugs
Distribution
California

Products covered by this recall

Losartan potassium tablets

What the company announced

Teva Pharmaceuticals USA, Inc. has expanded its voluntary consumer-level recall originally initiated on April 25, 2019 in the United States of losartan potassium tablets. This expanded recall includes six (6) lots of bulk losartan potassium USP Tablets (two lots of 50 mg strength and four lots of 100 mg strength) due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. The source of the NMBA impurity was detected in one lot of active pharmaceutical ingredient (API), manufactured by Hetero Labs Limited, which was used in the manufacturing of the six (6) bulk lots of these drug products. Based on the available information, there is a potential risk of developing cancer in a few patients following long-term use of products containing high levels of NMBA.

For more information on the previous recall initiated on April 25, 2019, click here.

Losartan potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients. The bulk lots were sold exclusively to Golden State Medical Supply, Inc. of Camarillo, California. Golden State Medical Supply, Inc. packaged these bulk products under its own label and distributed retail bottles of 30, 90 and 1000 tablets to their customers.

The affected losartan potassium tablets being recalled are described as:

Losartan potassium tablets, USP 50 mg, are green, film-coated, oval-shaped biconvex tablets with “LK 50” on one side and ">" on the other side.

Losartan potassium tablets, USP 100 mg, are dark green, film-coated, oval-shaped biconvex tablets with “LK100” on one side and ">" on the other side.

Teva promptly notified Golden State Medical Supply, Inc. of the presence of the impurity in Hetero’s API and Teva will recall six (6) lots of bulk losartan potassium tablets sold to that company. The tablets, which have been packaged and sold by Golden State Medical Supply, Inc., will be sub-recalled from their customers and patients. Distributors and retailers that have product being recalled should immediately stop distribution, quarantine all remaining product in their control, and return the recalled product per the instructions given to them by Golden State Medical Supply, Inc.

Patients taking losartan potassium tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. The immediate risk of harm to a patient’s health is likely to be higher if the medicine is stopped abruptly without any alternative treatment. For full drug product information, please refer to the full prescribing information for losartan potassium tablets USP.

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

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.

Lots Under Voluntary Recall

The finished product lots that are included in this voluntary recall and listed below were sold by Teva in bulk containers. The bulk tablet lots were repackaged into seven (7) finished product lots for further distribution by Golden State Medical Supply under its product label.

  • GSMS FG NDCs: 60429-317-10 · GSMS FG NDC Description: LOSARTAN POTASSIUM 50 mg TABLETS, USP 1000 tablets/bottle · GSMS FG Product Lots: GS017387 · GSMS FG Expiration Dates: 01/2020
  • GSMS FG NDCs: 60429-317-90 · GSMS FG NDC Description: LOSARTAN POTASSIUM 50 mg TABLETS 90 tablets/bottle · GSMS FG Product Lots: GS017651 · GSMS FG Expiration Dates: 01/2020
  • GSMS FG NDCs: 60429-317-30 · GSMS FG NDC Description: LOSARTAN POTASSIUM 50 mg TABLETS 30 tablets/bottle · GSMS FG Product Lots: GS017479 · GSMS FG Expiration Dates: 01/2020
  • GSMS FG NDCs: 60429-318-90 · GSMS FG NDC Description: LOSARTAN POTASSIUM 100 mg TABLETS 90 tablets/bottle · GSMS FG Product Lots: GS017042 · GSMS FG Expiration Dates: 01/2020
  • GSMS FG NDCs: 60429-318-90 · GSMS FG NDC Description: LOSARTAN POTASSIUM 100 mg TABLETS 90 tablets/bottle · GSMS FG Product Lots: GS017043 · GSMS FG Expiration Dates: 01/2020
  • GSMS FG NDCs: 60429-318-90 · GSMS FG NDC Description: LOSARTAN POTASSIUM 100 mg TABLETS, USP 90 tablets/bottle · GSMS FG Product Lots: GS017044 · GSMS FG Expiration Dates: 01/2020
  • GSMS FG NDCs: 60429-318-90 · GSMS FG NDC Description: LOSARTAN POTASSIUM 100 mg TABLETS, USP 90 tablets/bottle · GSMS FG Product Lots: GS017541 · GSMS FG Expiration Dates: 01/2020

Note – “GSMS FG” refers to Golden State Medical Supply Finished Goods.

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 877-789-2065 (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.

Customers of Golden State Medical Supply, Inc. may contact them at:

Call: (800) 284-8633, ext. 215

Fax: (805) 437-7582

Email: [email protected]

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 13 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
  • GS017387
  • GS017651
  • GS017479
  • GS017042
  • GS017043
  • GS017044
  • GS017541

Best-by / use-by date

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

  • 01/2020. GSMS FG
  • 01/2020

Package size

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

  • 50 mg
  • 100 mg

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

GSMS — 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. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.
  3. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.
  4. Call your prescriber or pharmacist and ask whether to swap the lot, re-test, or change nothing.

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: Teva Pharmaceuticals USA, Inc. — Consumers: Teva Medical Information, 888-838-2872, option 3, then, option 4, [email protected] — Media: Eric Rubin, Kelley Dougherty, 973-265-3759, 973-658-0237

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 GSMS prescription & otc drugs recalled?

Detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) Detection of an impurity – 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, GS017387; best-by date 01/2020. GSMS FG or 01/2020. 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.

Which states were affected?

The notice lists California.

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