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Ketorolac Tromethamine Painkiller Recall Expanded

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NSAID Injections Pulled for Unknown Substance

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 1-800-RxWatch 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.

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