FDA Recall D-0864-2020

Hikma Pharmaceuticals USA Inc. · Cherry Hill, NJ

Class I — life-threatening Terminated 540 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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.

Lot / code: 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

Quantity: 101,710 25 vials/shelf-pack

Reason for recall

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

Recall record

Recall number: D-0864-2020
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2019-12-17
Classified by FDA Center: 2020-03-02
FDA published: 2020-01-22
Terminated: 2021-06-09
Recalling firm: Hikma Pharmaceuticals USA Inc.
Firm location: Cherry Hill, NJ

Drug identification

Brand name(s): KETOROLAC TROMETHAMINE
Generic name(s): KETOROLAC TROMETHAMINE
Manufacturer(s): Hikma Pharmaceuticals USA Inc.
NDC(s): 0641-6041, 0641-6043, 0641-6042
Route(s): INTRAMUSCULAR, INTRAVENOUS

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