Class II · Moderate risk
Dexamethasone Moxifloxacin Ketorolac
Presence of particulate matter - Glass like particles.
Ketorolac Tromethamine Inj.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01.
Affected NDC
0409-3796-01
Compare with the code on your package — it is the most precise check available.
Drug: Ketorolac
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Ketorolac Tromethamine NDC 00409-3796 |
60 mg/2mL | Injection, Solution Intramuscular |
Hospira, Inc. | Rx |
- Recalling firm
- Hospira Inc.
- NDC code
- 0409-3796-01
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0388-2015 · 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 Ketorolac recalls
See all
Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Incorrect Product Formulation
Class II · Moderate risk
R.E.C.K.
Presence of Particulate Matter
Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter: Particulate matter identified as glass
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
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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