Recalls / Class II
Class IID-0658-2020
Product
Ketorolac 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.
- Brand name
- Ketorolac Tromethamine
- Generic name
- Ketorolac Tromethamine
- Active ingredient
- Ketorolac Tromethamine
- Route
- Intramuscular, Intravenous
- NDCs
- 0641-6041, 0641-6043, 0641-6042
- FDA application
- ANDA075772
- Affected lot / code info
- 038368, Exp. Mar 2020; 058314, Exp. May 2020; 078305, 078307, Exp. July 2020; 118362 Exp. Nov 2020
Why it was recalled
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Recalling firm
- Firm
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Esterbrook Ln, Cherry Hill, New Jersey 08003-4002
Distribution
- Quantity
- 25,817 shelf packs/25 vials per pack
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-12-17
- FDA classified
- 2020-03-02
- Posted by FDA
- 2020-01-22
- Terminated
- 2021-06-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0658-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.