Monday, March 9, 2020 - Hikma Pharmaceuticals USA Inc. has expanded a voluntary recall of West-Ward brand Ketorolac Tromethamine Injection, USP 30mg/mL in 1 mL vials due to an unknown contaminant that has left visible particles of a black gelatinous substance in some lots.
Some vials of the NSAID pain reliever, marketed for short-term use for patients who require pain management at the opioid level, were recalled December 23, 2019. The latest recall expands the recall from direct customer use to also include medical facilities and retail pharmaceutical outlets.
The concern with the recalled drugs is that the small particles found in some vials can deposit themselves in patients' lungs, eventually causing acute respiratory distress.
Recalled lots, all with NDC #0641-6042-25, include:
Lot 038366 Expiration Mar-2020
Lot 048365 Expiration Apr-2020
Lot 048367 Expiration Apr-2020
Lot 078301 Expiration Jul-2020
Lot 078303 Expiration Jul-2020
Lot 118358 Expiration Nov-2020
Lot 019413 Expiration Jan-2021
Lot 029353 Expiration Feb-2021
No adverse effects have been reported to-date, according to the FDA. Patients should contact their healthcare provider if they experience respiratory difficulty while using Ketorolac Tromethamine injections.
If you have experienced a dangerous adverse effect from a medication or medical device, contact OnderLaw at 314-963-9000 for a free, no-obligation consultation. We work hard to hold manufacturers accountable for dangerous products, and to protect consumers from suffering needless injury or death.
OnderLaw, LLC in St. Louis has developed a solid reputation of excellence as a personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation, including Pradaxa, Lexapro and Yasmin/Yaz, Actos, Risperdal and others. The Onder Law Firm has won verdicts of more than $300 million in talcum powder ovarian cancer lawsuits, and has more experience representing Bayer/Monsanto glyphosate cancer victims than any other law firm in the country.