Class I · Most seriousRecall completed
Ketorolac Tromethamine
A reasonable chance it could cause serious harm or death.
Does this affect you?
Check your lot numberLot #: 038366, Exp. Date Mar 2020; 048365, 048367, Exp. Date Apr 2020; 078301, 078303, Exp. Date July 2020; 118358, Exp. Date Nov 2020; 029353, Exp. Date Feb 2021; 019413, Exp. Date Jan 2021
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
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- 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 name | KETOROLAC TROMETHAMINE |
| Generic name | KETOROLAC TROMETHAMINE |
| Active ingredient(s) | KETOROLAC TROMETHAMINE |
| Distributed by / for | Hikma Pharmaceuticals USA Inc. |
| NDC | 0641-6042-01 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | Hikma Pharmaceuticals USA Inc. |
| Distribution | Nationwide within the United States |
| Quantity | 101,710 25 vials/shelf-pack |
| Recall initiated | 2019-12-17 |
| Report date | 2020-01-22 |
| Recall completed | 2021-06-09 |
| Recall number | D-0864-2020 |
| Classification | Class I |
| FDA status | Terminated |
| Origin on file | Cherry Hill NJ United States |
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.