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Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (...

FDA Recall #D-0658-2020 — Class II — December 17, 2019

Recall #D-0658-2020 Date: December 17, 2019 Classification: Class II Status: Terminated

Product Description

Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.

Reason for Recall

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

Recalling Firm

Hikma Pharmaceuticals USA Inc. — Cherry Hill, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

25,817 shelf packs/25 vials per pack

Distribution

Nationwide within the United States

Code Information

038368, Exp. Mar 2020; 058314, Exp. May 2020; 078305, 078307, Exp. July 2020; 118362 Exp. Nov 2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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