Pfizer Inc. recalls Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira,
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Recall notice
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
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Source Page by GovInfoNow · govinfonow.com/recall/39672-pfizer-inc-recalls-argatroban-injection-250-mg-2-5-ml · Recall date August 28, 2018 · FDA enforcement record: FDA #D-1184-2018
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“Pfizer Inc. recalls Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira,.” GovInfoNow, recall dated August 28, 2018. https://govinfonow.com/recall/39672-pfizer-inc-recalls-argatroban-injection-250-mg-2-5-ml. Based on FDA recall #D-1184-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1184-2018%22&limit=1).
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We’ve drafted a message you can send PFIZER INC to request your refund or repair — edit it as you like.
Subject: Recall D-1184-2018 — PFIZER INC Pfizer Inc. recalls Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use V Hello, I own a Pfizer Inc. recalls Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, that is covered by recall D-1184-2018 from PFIZER INC. 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-1184-2018 (August 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1184-2018 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.