Class III · Low risk
Hydromorphone HCL PF
Labeling: Incorrect or Missing Lot and/or Exp Date
Hydromorphone Hydrochloride Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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 By: Hospira Inc., Lake Forest, IL 60045; Mfd For: Teva 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.
Affected NDCs
0409-2634-01
0703-0110-01
0703-0110-03
Compare with the code on your package — it is the most precise check available.
Drug: Hydromorphone
Product details
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Hydromorphone Hydrochloride NDC 00409-2634 |
10 mg/mL | Injection, Solution Intramuscular|intravenous|subcutaneous |
Hospira, Inc. | Rx · CII |
| Hydromorphone Hydrochloride NDC 00703-0110 |
10 mg/mL | Injection, Solution Intramuscular|intravenous|subcutaneous |
Teva Parenteral Medicines, Inc. | Rx · CII |
- Recalling firm
- Hospira Inc.
- NDC code
- 0703-0110-01
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0044-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydromorphone recalls
See all
Class III · Low risk
HYDROmorphone Hydrochloride 50mg/50mL
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Class II · Moderate risk
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Other recalls by Hospira Inc.
All 2014 recalls
Class I · High risk
Infant 25% DEXTROSE Injection
Presence of Particulate Matter: human hair found within an internal sample syringe.
Class II · Moderate risk
Fentanyl Citrate Injection
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Class II · Moderate risk
DOBUTamine Injection
Discoloration: Firm received complaints of product discoloration and particulates.
Class III · Low risk
5% Lidocaine HCL and 7.5% Dextrose Injection
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
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