Reported Jan 22, 2020 · Terminated
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25…
Hikma Pharmaceuticals USA Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hikma Pharmaceuticals USA Inc. · 2 Esterbrook Ln · Cherry Hill, NJ · 08003-4002
Is this the product you have?
- 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 byWEST-WARD Eatontown, NJ 07724 USA
- Lot codes and dates
Lot #: 038366Exp. Date Mar 2020048365048367Exp. Date Apr 2020078301078303Exp. Date July 2020118358Exp. Date Nov 2020029353Exp. Date Feb 2021019413Exp. Date Jan 2021
- Amount recalled
- 101,710 25 vials/shelf-pack
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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