Blog

Hospira, Inc., a Pfizer company, is voluntarily recalling three lots of Hydromorphone HCl Injection, USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials lot numbers 71330DD (NDC 0409-2634-01), and 691853F and 700753F (NDC 0703-0110-01 – Teva lots) to the hospital/institution level. Hospira, Inc. initiated this recall on February 07, 2018 due to the potential that units from these lots may be empty or cracked at the bottom of the glass vial.

Cracked vials may compromise the sterility of the product. Use of or exposure to cracked units may be associated with adverse events such as sharps injury to healthcare professionals. Intravenous infusion of a non-sterile solution can lead to bloodstream infections, which may potentially lead to bacteremia or sepsis. These infections are of concern especially to immunocompromised patients. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

Hydromorphone HCl is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is also indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Hydromorphone HCl Injection, USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials, is packaged in a carton of 10 x 1 mL Single- dose vials. The affected lots include the following NDC, lot numbers and expiry dates. Product was distributed nationwide to wholesalers/distributors/retailers/hospitals in the United States and Puerto Rico from October 2016 to July 2017.

Read the full FDA article published April 13, 2020

Hikma Pharmaceuticals PLC (Hikma, Group), announced March 04, 2020 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 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.

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.

See what lots were recalled and read the full article published by the FDA on March 5, 2020