Hospira Inc.: KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS

Is my product affected?

KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49

• Brand KETOROLAC TROMETHAMINE

Check against the official notice below — it lists the full affected range.

What happened

Hospira Inc. is recalling Ketorolac Tromethamine injections (60 mg, 30 mg/mL, 2 mL single-dose vials for intravenous or intramuscular use) because the medication has crystallized, with the crystalline material identified as a calcium salt of Ketorolac. The recall affects over 5.2 million vials distributed nationwide as well as in Puerto Rico, Guam, Canada, and Singapore, along with over 250,000 vials labeled under the NOVAPLUS brand. Multiple lot numbers are involved with expiration dates ranging from July 2015 through October 2016.

The recall covers specific lot codes including 31075DK, 31076DK, 32345DK, 32368DK, 33152DK, 34538DK, 37227DK, 41525DK, 42255DK, 46042DK, 46045DK, 46048DK, 46304DK, 46305DK, 46432DK, 46433DK, and NOVAPLUS lot 31074DK. The source document does not specify a remedy or action for affected consumers to take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Crystallization; identified as calcium salt of Ketorolac

Details from the source

Reason for recall: Crystallization; identified as calcium salt of Ketorolac Distribution: Nationwide, Puerto Rico, Guam, Canada and Singapore Quantity: 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label) Lot/code info: 31075DK, 31076DK, EXP01JUL2015; 32345DK, 32368DK, EXP 01AUG2015; 33152DK, EXP 01SEP2015; 34538DK, EXP 01OCT2015; 37227DK, EXP 01JAN2016, 41525DK, 42255DK, EXP 01MAY2016; 46042DK, 46045DK, 46048DK, 46304DK, 46305DK, 46432DK, 46433DK, EXP 01OCT2016 AND NOVAPLUS LOT 31074DK, EXP 01JUL2015

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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 0409-3795-492015-06-30
• 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 0409-3795-492015-01-23
• KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-492015-01-23
• Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01.2014-10-06
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All FDA (Drug enforcement) recalls