Ketorolac Tromethamine - manufacturers, supply & price · Pillstats

Who makes it25 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

Labeler	Type	Packages	Status
Fresenius Kabi, USA LLC	generic	14	SUPPLYING
Eugia US LLC	generic	7	SUPPLYING
HF Acquisition Co LLC, DBA HealthFirst	repackager	7	SUPPLYING
Hospira, Inc.	brand	6	SUPPLYING
Baxter Healthcare Corporation	brand	5	SUPPLYING
Cardinal Health 107, LLC	repackager	5	SUPPLYING
Medical Purchasing Solutions, LLC	repackager	4	SUPPLYING
REMEDYREPACK INC.	repackager	4	SUPPLYING
Anthea Pharma Private Limited	unknown	4	SUPPLYING
Civica, Inc.	unknown	4	SUPPLYING
Camber Pharmaceuticals, Inc.	generic	4	SUPPLYING
Asclemed USA, Inc.	repackager	4	SUPPLYING
Sagent Pharmaceuticals	generic	3	SUPPLYING
Fosun Pharma USA Inc.	unknown	3	SUPPLYING
Northstar Rx LLC	relabeler	3	SUPPLYING

+ 10 more labelers

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

Sep 25, 2026
ENTRYNew US registration: ketorolac tromethamine — Anthea Pharma Private Limited (NDC 83854-024)
Sep 25, 2026
ENTRYNew US registration: ketorolac tromethamine — Anthea Pharma Private Limited (NDC 83854-021)
Sep 25, 2026
ENTRYNew US registration: ketorolac tromethamine — Anthea Pharma Private Limited (NDC 83854-022)
Oct 1, 2025
RECALLRecall (Class II): Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx onl…
Presence of Particulate Matter: Particulate matter identified as glass — Recalling firm: Aspiro Pharma Limited — Nationwide within the United States
Dec 23, 2020
RECALLRecall (Class I): Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL S…
Presence of Particulate Matter - found in reserve sample vials at the firm. — Recalling firm: Fresenius Kabi USA, LLC — Nationwide USA and Puerto Rico
Dec 17, 2020
RECALLRecall (Class II): Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Frese…
Presence of Particulate Matter - found in reserve sample vials at the firm. — Recalling firm: Fresenius Kabi USA, LLC — USA Nationwide and Puerto Rico
Apr 20, 2020
RECALLRecall (Class II): Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162…
Presence of Particulate Matter - found in reserve sample vials at the firm. — Recalling firm: Fresenius Kabi USA, LLC — USA Nationwide and Puerto Rico
Apr 20, 2020
RECALLRecall (Class I): Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL S…
Presence of Particulate Matter - found in reserve sample vials at the firm. — Recalling firm: Fresenius Kabi USA, LLC — USA Nationwide and Puerto Rico
Apr 30, 2019
RECALLRecall (Class II): Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuti…
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products. — Recalling firm: Sagent Pharmaceuticals Inc — Nationwide USA and Puerto Rico
Jun 6, 2018
SHORTAGEDrug shortage: Ketorolac Tromethamine Injection (Baxter Healthcare)
Ketorolac Tromethamine Injection — reported in shortage by Baxter Healthcare. Therapeutic category: Analgesia/Addiction.
Mar 26, 2018
SHORTAGEDrug shortage: Ketorolac Tromethamine Injection (Sagent Pharmaceuticals)
Ketorolac Tromethamine Injection — reported in shortage by Sagent Pharmaceuticals. Therapeutic category: Analgesia/Addiction.
Mar 26, 2018
SHORTAGEDrug shortage: Ketorolac Tromethamine Injection (Hospira, Inc., a Pfizer Company)
Ketorolac Tromethamine Injection — reported in shortage by Hospira, Inc., a Pfizer Company. Therapeutic category: Analgesia/Addiction.
Mar 23, 2018
SHORTAGEDrug shortage: Ketorolac Tromethamine Injection (Gland Pharma Limited)
Ketorolac Tromethamine Injection — reported in shortage by Gland Pharma Limited. Therapeutic category: Analgesia/Addiction.
Mar 23, 2018
SHORTAGEDrug shortage: Ketorolac Tromethamine Injection (Fresenius Kabi USA, LLC)
Ketorolac Tromethamine Injection — reported in shortage by Fresenius Kabi USA, LLC. Therapeutic category: Analgesia/Addiction.
Jun 30, 2015
RECALLRecall (Class II): KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake For…
Crystallization; identified as calcium salt of Ketorolac — Recalling firm: Hospira Inc. — Nationwide, Puerto Rico, Guam, Canada and Singapore
Jun 30, 2015
RECALLRecall (Class II): KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Fore…
Crystallization; identified as calcium salt of Ketorolac — Recalling firm: Hospira Inc. — Nationwide, Puerto Rico, Guam, Canada and Singapore
Jan 23, 2015
RECALLRecall (Class II): KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Fore…
Crystallization — Recalling firm: Hospira Inc. — U.S. Nationwide and International: Guam and Singapore.
Jan 23, 2015
RECALLRecall (Class II): KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake For…
Crystallization — Recalling firm: Hospira Inc. — U.S. Nationwide and International: Guam and Singapore.
Oct 6, 2014
RECALLRecall (Class II): Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx …
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. — Recalling firm: Hospira Inc. — Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorola…
Oct 3, 2014
RECALLRecall (Class II): Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), R…
Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date. — Recalling firm: Sagent Pharmaceuticals Inc — Nationwide and Puerto Rico
Aug 12, 2013
RECALLRecall (Class II): Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials. — Recalling firm: Hospira, Inc. — Naitonwide

Ketorolac Tromethamine

US acquisition costNADAC · per unit

Medicaid dispensing volumeSDUD · per quarter

Who makes it25 active · 0 exited

Regulatory & supply eventsFDA · US