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Drug recall · FDA · Published July 29, 2016

Teva Pharmaceuticals USA recalls Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals

CGMP Deviations

🇺🇸 FDA recall #D-0023-2017DrugTeva Pharmaceuticals USA ›
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Recalling firmTeva Pharmaceuticals USA1090 Horsham Rd, N/A · North Wales, PA 19454-1505
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
Write-up in progress

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Source Page by GovInfoNow · govinfonow.com/recall/42510-teva-pharmaceuticals-usa-recalls-amikacin-sulfate-injection-usp-500-mg · Recall date July 29, 2016 · FDA enforcement record: FDA #D-0023-2017

Cite this page

“Teva Pharmaceuticals USA recalls Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals.” GovInfoNow, recall dated July 29, 2016. https://govinfonow.com/recall/42510-teva-pharmaceuticals-usa-recalls-amikacin-sulfate-injection-usp-500-mg. Based on FDA recall #D-0023-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0023-2017%22&limit=1).

How to tell if you have this one

  • Brand
    Teva Pharmaceuticals USA
  • Category
    Drug
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide and Puerto Rico
Recall numberProduct, codes & lotsQuantity
D-0023-2017Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).; Lot # 7080315, 7400315, 7410315, 798041527,547 vials
D-0024-2017Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).; Lot # 2381114, 2771114, 476091511,844 vials
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Contact Teva Pharmaceuticals USA

We’ve drafted a message you can send Teva Pharmaceuticals USA to request your refund or repair — edit it as you like.

Subject: Recall D-0023-2017 — Teva Pharmaceuticals USA Teva Pharmaceuticals USA recalls Amikacin Sulfate Injection, USP, 500 mg/2

Hello,

I own a Teva Pharmaceuticals USA recalls Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals that is covered by recall D-0023-2017 from Teva Pharmaceuticals USA.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0023-2017 (July 29, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0023-2017 to see it in context.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA