Reported Oct 29, 2014 · Terminated
Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01),…
Hospira 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: Hospira Inc. · 275 N Field Dr · Lake Forest, IL · 60045-2579
Is this the product you have?
- Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0703-0110-03)
- Mfd ByHospira Inc., Lake Forest, IL 60045
- Mfd ForTeva Parenteral Medicines, Inc., Irvine, CA 92618; and b) 1 mL Single-dose Vial, packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0409-2634-01), Hospira, Inc., Lake Forest, IL 60045
- Lot codes and dates
Lot #: a) 260753F261403FExp 1FEB2015290153FExp 1MAY2015b) 24-080-DDExp 1DEC201425-475-DDExp 1JAN2015
- Amount recalled
- 145,600 vials
Where it was sold
- Nationwide
Why it was recalled
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
This product could cause temporary or reversible health problems — stop using it.
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