Recalls / Class I
Class ID-0864-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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.
- 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
- Lot #: 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
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
- 101,710 25 vials/shelf-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-0864-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.