Is Tromethamine recalled?

48 FDA recalls mention Tromethamine. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Tromethamine.

Class II · Moderate risk Terminated Dec 17, 2020

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi…

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

Fresenius Kabi USA, LLC NDC 63323-162-02 D-0184-2021

Class II · Moderate risk Terminated Apr 20, 2020

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x…

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

Fresenius Kabi USA, LLC NDC 63323-162-03 D-1297-2020

Class I · High risk Terminated Apr 20, 2020

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

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

Fresenius Kabi USA, LLC NDC 63323-162-00 D-1296-2020

Class I · High risk Terminated Dec 17, 2019

Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC…

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

Hikma Pharmaceuticals USA Inc. NDC 0641-6042-01 D-0864-2020

Class II · Moderate risk Terminated Dec 17, 2019

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

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

Hikma Pharmaceuticals USA Inc. NDC 0641-6043-01 D-0658-2020

Class II · Moderate risk Terminated Sep 12, 2019

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5…

Reason Lack of Assurance of Sterility

KRS Global Biotechnology, Inc D-0116-2020

Class II · Moderate risk Terminated Sep 12, 2019

Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5…

Reason Lack of Assurance of Sterility

KRS Global Biotechnology, Inc D-0108-2020

Class II · Moderate risk Terminated Sep 12, 2019

Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac…

Reason Lack of Assurance of Sterility

KRS Global Biotechnology, Inc D-0106-2020

Class II · Moderate risk Terminated Apr 30, 2019

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals…

Reason Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential…

Sagent Pharmaceuticals Inc D-1274-2019

Class II · Moderate risk Terminated Aug 15, 2017

Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc…

Reason Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.

Amphastar Pharmaceuticals, Inc. NDC 0548-9021-00 D-1124-2017

Class II · Moderate risk Ongoing Jun 30, 2015

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…

Reason Crystallization; identified as calcium salt of Ketorolac

Hospira Inc. NDC 0409-3796-01 D-1242-2015

Class II · Moderate risk Ongoing Jun 30, 2015

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…

Reason Crystallization; identified as calcium salt of Ketorolac

Hospira Inc. NDC 0409-3795-01 D-1241-2015

Class II · Moderate risk Terminated Apr 13, 2015

Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC…

Reason Crystallization

Hospira Inc. NDC 00409-3796-01 D-0973-2015

Class II · Moderate risk Terminated Apr 13, 2015

Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC…

Reason Crystallization

Hospira Inc. NDC 00409-3795-01 D-0972-2015

Class II · Moderate risk Terminated Jan 23, 2015

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…

Reason Crystallization

Hospira Inc. NDC 0409-3796-01 D-0483-2015

Class II · Moderate risk Terminated Jan 23, 2015

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…

Reason Crystallization

Hospira Inc. NDC 0409-3795-01 D-0482-2015

Class II · Moderate risk Terminated Jan 21, 2015

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd…

Reason Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.

Sun Pharma Global Fze NDC 41616-219-90 D-0394-2015

Class II · Moderate risk Terminated Nov 14, 2014

Ketorolac Tromethamine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…

Attix Pharmaceuticals D-743-2015

Class II · Moderate risk Terminated Oct 6, 2014

Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only…

Reason Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

Hospira Inc. NDC 0409-3796-01 D-0388-2015

Class II · Moderate risk Terminated Oct 3, 2014

Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only…

Reason Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect…

Sagent Pharmaceuticals Inc NDC 25021-701-01 D-0027-2015

Class II · Moderate risk Terminated Aug 12, 2013

Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01

Reason Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.

Hospira, Inc. NDC 0409-3795-01 D-926-2013

Class II · Moderate risk Terminated Jul 26, 2013

KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by…

Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…

Beacon Hill Medical Pharmacy, P.C. D-971-2013

Class II · Moderate risk Terminated May 21, 2012

KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE 10 ML 24 ML 500 ML; KETOROLAC TROMETHAMINE 60MG/ML INJECTABLE 48 ML…

Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…

Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1552-2012

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