Class II · Moderate risk Ongoing
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC…
Reason Presence of particulate matter - Glass like particles.
Ketorolac Injection, all strengths and all presentations including a) Ketorolac 30 mg/mL…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
What was recalled
Ketorolac Injection, all strengths and all presentations including a) Ketorolac 30 mg/mL 10 mL MDV, b) Ketorolac 30 mg/mL 2 mL SDV, c) Ketorolac 30 mg/mL 1 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
- Recalling firm
- FVS Holdings, Inc. dba. Green Valley Drugs
- Origin
- NV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-376-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Ketorolac recalls
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Class II · Moderate risk Ongoing
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For…
Reason Incorrect Product Formulation
Class II · Moderate risk Ongoing
R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50…
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd…
Reason Presence of Particulate Matter: Particulate matter identified as glass
Class II · Moderate risk Ongoing
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario…
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
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