Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP 30mg/mL, 1mL Fill/2mL Vials Due to the Potential Presence of Small Particulates

London, March 4, 2020 – Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA Inc. (formerly known as West-Ward Pharmaceuticals Corp.; “Hikma”) is voluntarily extending its previously-announced recall of certain lots (listed below) of Ketorolac Tromethamine Injection USP 30mg/mL, 1mL fill/2mL vials to the medical facility and retail levels. The product is being recalled due to the presence of small visible particulate matters of a gelatinous/oily nature that appear black in some of the recalled lots.

Press Release Corporate 4 March 2020

text 1

On December 23, 2019, Hikma voluntarily initiated a recall of this product to the direct customer level.  In coordination with the U.S. Food and Drug Administration (FDA), Hikma is extending the recall to the medical facility and retail levels.

Administration of the affected product could potentially result in the deposition of particulates in the lungs of patients, which could result in multiple pulmonary microemboli with subsequent acute respiratory distress for patients receiving the drug intravenously.

Although Hikma has not received any reports of adverse events related to this issue, it is nonetheless extending its recall of these products out of an abundance of caution and to promote patient safety, which is Hikma’s highest priority.

The lots being recalled were manufactured between March 22, 2018, and February 21, 2019.  Hikma investigated the cause of the problem and decided to suspend manufacturing of this product until an appropriate solution can be implemented to prevent recurrence.

Ketorolac Tromethamine Injection is a nonsteroidal anti-inflammatory drug (“NSAID”) that is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level.

The affected lot numbers and expiration dates being recalled are as follows:

NDC

Product Name and Strength

Size

Lot Number

Expiration Date

0641-6042-25

Ketorolac Tromethamine Injection 30mg/mL

1mL Fill/2mL Vial

038366

Mar-2020

0641-6042-25

Ketorolac Tromethamine Injection 30mg/mL

1mL Fill/2mL Vial

048365

Apr-2020

0641-6042-25

Ketorolac Tromethamine Injection 30mg/mL

1mL Fill/2mL Vial

048367

Apr-2020

0641-6042-25

Ketorolac Tromethamine Injection 30mg/mL

1mL Fill/2mL Vial

078301

Jul-2020

0641-6042-25

Ketorolac Tromethamine Injection 30mg/mL

1mL Fill/2mL Vial

078303

Jul-2020

0641-6042-25

Ketorolac Tromethamine Injection 30mg/mL

1mL Fill/2mL Vial

118358

Nov-2020

0641-6042-25

Ketorolac Tromethamine Injection 30mg/mL

1mL Fill/2mL Vial

019413

Jan-2021

0641-6042-25

Ketorolac Tromethamine Injection 30mg/mL

1mL Fill/2mL Vial

029353

Feb-2021

The product can be identified by name and NDC and lot codes, which are clearly stated on the product label, along with Hikma Pharmaceuticals USA Inc./West-Ward Pharmaceutical Corp.’s name and address.  Images of the vial and shelf pack labels are included below:

The product was distributed to Hikma’s direct customers nationwide.  Hikma notified its direct customers as part of the initial recall, asking them to contact medical and retail level facilities to locate and remove the recalled product from distribution channels and return the recalled lots to Hikma. Hikma is now asking customers at the medical and retail level facilities to locate and remove the recalled product from their channels and return the recalled lots to Hikma.

For recall inquiries, please contact Hikma using the information provided below:

Hikma Contact

Contact Information

Areas of Support

Hikma Pharmaceuticals USA Inc. – Customer Service

(P): (800) 631-2174

(E): usrecall@hikma.com

(F): (732) 542-0940

Hours of operation, M-F: 8:00am-7pm (EST)

Recall related inquires

Qualanex LLC (Hikma 3rd Party Recall Service Provider)

Qualanex LLC

1410 Harris Road

Libertyville, IL 60048-2435

(E): recall@qualanex.com

Product Returns

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Important notice for users

You are about to access Hikma historic archive material. Any reference in these archives to Hikma products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data, or safety data. Please refer to your approved national product label (SmPC) for current product information.

I have read this warning and will not be using any of the contained product information for clinical purposes.