Class II · Moderate risk
Dexamethasone Moxifloxacin Ketorolac
Presence of particulate matter - Glass like particles.
Ketorolac Tromethamine Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
Affected NDCs
0641-6042-01
0641-6042-25
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 00641-6042 |
30 mg/mL | Injection Intramuscular|intravenous |
Hikma Pharmaceuticals USA Inc. | Rx |
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- NDC code
- 0641-6042-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0864-2020 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. 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 Hikma Pharmaceuticals USA Inc.
All 2019 recalls
Class II · Moderate risk
Ramipril Capsules USP
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Class II · Moderate risk
Alendronate Sodium Oral Solution
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Class II · Moderate risk
Lorazepam Injection
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Class I · High risk
Acetaminophen Injection
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
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