Hikma Pharmaceuticals USA announced that the voluntary recall of Ketorolac Tromethamine Injection 30mg/mL vials has been extended to include additional lots. The product is being recalled due to the presence of small black particulate matter of a gelatinous/oily nature that is visible in the vial.
The recalled lots of Ketorolac Tromethamine Injection 30mg/mL (NDC 0641-6042-25; Size 1mL Fill/2mL vial) were manufactured between March 22, 2018 and February 21, 2019, and include the following lot numbers and expiry dates:
- Lot Number 038366; Exp Date Mar 2020
- Lot Number 048365; Exp Date Apr 2020
- Lot Number 048367; Exp Date Apr 2020
- Lot Number 078301; Exp Date Jul 2020
- Lot Number 078303; Exp Date Jul 2020
- Lot Number 118358; Exp Date Nov 2020
- Lot Number 019413; Exp Date Jan 2021
- Lot Number 029353; Exp Date Feb 2021
Ketorolac tromethamine injection, a nonsteroidal anti-inflammatory drug, is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. According to Hikma, “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.”
Hikma has notified customers at medical and retail level facilities to remove all affected products from distribution and return any recalled products. Additionally, the Company has suspended the manufacturing of this product until further notice. Adverse reactions may be reported to the FDA’s MedWatch program.
For more information regarding this recall, contact Hikma Pharmaceuticals at (800) 631-2174 or email [email protected]