FDA Recall D-1241-2015

Hospira Inc. · Lake Forest, IL

Class II Ongoing 3971 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49

Lot / code: 31077DK, 31078DK, 31338DK, 31339DK, 31340DK, EXP 01JUL2015; 32068DK, 32069DK, EXP 01AUG2915; 33270DK, EXP 01SEP2015; 34084DK, 34085DK, 34161DK, 34162DK, 34298DK, 34299DK, 34300DK, EXP 01OCT2015; 35011DK, 35081DK, 35082DK, 35116DK, EXP 01NOV2015; 38139DK, 38140DK, 36144DK, EXP 01FEB2016; 39256DK, 39257DK, EXP 01MAR2016; 42210DK, 42227DK, EXP01JUN2016; 43017DK, 43116DK, 43117DK, 43292DK, 43293DK, EXP 01JUL2016; 45034DK, 45035DK, 45118DK, 45120DK, EXP 01SEP2016; 46310DK, 46311DK, EXP 01OCT2016 AND NOVAPLUS LOTS 32106DK, 32220DK, 32221DK, EXP 01AUG2015; 33235DK, 33236DK, EXP 01SEP2015; 34163DK, 34164DK, EXP 01OCT2015; 39263DK, 39264DK, EXP 01MAR2016

Quantity: 12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label)

Reason for recall

Crystallization; identified as calcium salt of Ketorolac

Recall record

Recall number: D-1241-2015
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide, Puerto Rico, Guam, Canada and Singapore
Recall initiated: 2015-06-30
Classified by FDA Center: 2015-07-15
FDA published: 2015-07-22
Recalling firm: Hospira Inc.
Firm location: Lake Forest, IL

Drug identification

Brand name(s): KETOROLAC TROMETHAMINE
Generic name(s): KETOROLAC TROMETHAMINE
Manufacturer(s): Hospira, Inc.
NDC(s): 0409-3793, 0409-3795, 0409-3796
Route(s): INTRAMUSCULAR, INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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