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Class II · ModerateRecall completed

Ketorolac Tromethamine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot number038368, Exp. Mar 2020; 058314, Exp. May 2020; 078305, 078307, Exp. July 2020; 118362 Exp. Nov 2020
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byWEST-WARD Eatontown, NJ 07724 USA
Brand nameKETOROLAC TROMETHAMINE
Generic nameKETOROLAC TROMETHAMINE
Active ingredient(s)KETOROLAC TROMETHAMINE
Distributed by / forHikma Pharmaceuticals USA Inc.
NDC0641-6043-01
Show the full FDA record
Full product labelKetorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
Recalling firmHikma Pharmaceuticals USA Inc.
DistributionNationwide within the United States
Quantity25,817 shelf packs/25 vials per pack
Recall initiated2019-12-17
Report date2020-01-22
Recall completed2021-06-09
Recall numberD-0658-2020
ClassificationClass II
FDA statusTerminated
Origin on fileCherry Hill NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.