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Drug recall · FDA · Published July 26, 2017

HOSPIRA INC, LAKE FOREST recalls Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral

Presence of Particulate Matter: Silicone oil

🇺🇸 FDA recall #D-1080-2017DrugHOSPIRA INC, LAKE FOREST ›
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Recalling firmHOSPIRA INC, LAKE FOREST275 NORTH FOREST DRIVE, N/A · LAKE FOREST, IL 60045
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.
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Source Page by GovInfoNow · govinfonow.com/recall/41424-hospira-inc-lake-forest-recalls-hydromorphone-hydrochloride-injection-usp-500 · Recall date July 26, 2017 · FDA enforcement record: FDA #D-1080-2017

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“HOSPIRA INC, LAKE FOREST recalls Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral.” GovInfoNow, recall dated July 26, 2017. https://govinfonow.com/recall/41424-hospira-inc-lake-forest-recalls-hydromorphone-hydrochloride-injection-usp-500. Based on FDA recall #D-1080-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1080-2017%22&limit=1).

How to tell if you have this one

  • Brand
    HOSPIRA INC, LAKE FOREST
  • Category
    Drug
FDA recall event · 3 products

All 3 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 in the USA
Recall numberProduct, codes & lotsQuantityNDC
D-1080-2017Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01; Lot #: 560053F, Exp. 01AUG201714,300 vials0703-0110-01, 0703-0110-03, 0703-0113-01, 0703-0113-03, 0703-0018-01
D-1081-2017Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50; Lot #: 56260DD, Exp. 01AUG20179,009 vials0409-2634-10, 0409-2634-01, 0409-2634-25, 0409-2634-05, 0409-2634-50
D-1082-2017Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.; Lot #: 560103F, Exp. 01AUG201756,340 vials0703-0110-01, 0703-0110-03, 0703-0113-01, 0703-0113-03, 0703-0018-01
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Contact HOSPIRA INC, LAKE FOREST

We’ve drafted a message you can send HOSPIRA INC, LAKE FOREST to request your refund or repair — edit it as you like.

Subject: Recall D-1080-2017 — HOSPIRA INC, LAKE FOREST HOSPIRA INC, LAKE FOREST recalls Hydromorphone Hydrochloride Injection, US

Hello,

I own a HOSPIRA INC, LAKE FOREST recalls Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral that is covered by recall D-1080-2017 from HOSPIRA INC, LAKE FOREST.

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-1080-2017 (July 26, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1080-2017 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