Reported Sep 27, 2017 · Terminated
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira,…
Pfizer Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pfizer Inc. · 235 E 42nd St · New York, NY · 10017-5703
Is this the product you have?
- HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)
- Lot codes and dates
- Lot760853A
- Amount recalled
- 115,370 vials
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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