KETOROLAC TROMETHAMINE

Generic: KETOROLAC TROMETHAMINE

Aurobindo Pharma LimitedManufacturer
OPHTHALMICRoute
KETOROLAC TROMETHAMINEActive Substance
2020-12-03Original Approval

KETOROLAC TROMETHAMINE is FDA application ANDA205190, sponsored by EUGIA PHARMA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2019-04-30
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceutic

Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufactur

Class I2020-04-20
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Si

Presence of Particulate Matter - found in reserve sample vials at the firm.

Class II2015-06-30
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Fore

Crystallization; identified as calcium salt of Ketorolac

Class II2025-05-28
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada

Lack of Assurance of Sterility

Class II2015-06-30
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Fores

Crystallization; identified as calcium salt of Ketorolac

Class II2020-12-17
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresen

Presence of Particulate Matter - found in reserve sample vials at the firm.

Class II2014-10-06
Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx o

Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

Class II2015-01-23
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Fores

Crystallization

Class II2019-12-17
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 v

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

Class II2025-09-05
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, O

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to poten

Top Reported Reactions

1
DRUG INEFFECTIVE
472 reports
2
DRUG HYPERSENSITIVITY
298 reports
3
NAUSEA
244 reports
4
HEADACHE
232 reports
5
PAIN
230 reports
6
FATIGUE
212 reports
7
DYSPNOEA
208 reports
8
TREATMENT FAILURE
205 reports
9
VOMITING
158 reports
10
OFF LABEL USE
152 reports