The FDA is advising consumers that Hikma Pharmaceuticals PLC (Hikma, Group) has extended its retail-level and single-lot recall of Acetaminophen Injection, 1000mg/100mL (10mg/mL) to the consumer level, per an update on the agency’s website on July 22, 2024.
The company had voluntarily recalled all products under lot 24070381 on July 8, 2024, because of concerns that a bag labeled Dexmedetomidine HCL Injection (400mcg/100mL) may be found inside the overwrap, which is labeled for Acetaminophen Injection, 1000mg/100mL (10mg/mL).
In the event that a medical provider fails to discern the mislabeling and then administers dexmedetomidine instead of the intended acetaminophen, patients may suffer the following adverse health outcomes: a range of sedative effects, “bradypnea, bradycardia, hypertension, and hypotension,” as well as other more advanced and possibly life-threatening conditions.
Hikma says that it has received one report of an adverse event related to the recall to date. No information regarding the severity of the incident was provided in the announcement.
Indicated for use by adult and pediatric patients 2 years and older, Acetaminophen Injection is used in the management of mild to moderate pain, of moderate to severe pain “with adjunctive opioid analgesics,” and is used to reduce fever in the same group. Sterile, nonpyrogenic, and ready to use, the solution comes in IV bags designed to be infused intravenously. In composition, each 100 mL bag, the pH of which “may be adjusted with hydrochloric acid and/or sodium hydroxide,” contains the following for injection:
- 1,000 mg acetaminophen, USP,
- 193 mg anhydrous citric acide, USP,
- sodium chloride, USP (tonicity agent),
- water
Officials note that the recall covers products that were manufactured on March 19, 2024 (3/19/2024) and that are distinguished by the following details, as shown in the product photos provided in the FDA announcement:
- Hikma brand Acetaminophen Injection USP, 1,000 mg per 100 mL (10 mg/mL)
- NDC 0143-9386-100143-9386-01, Individual bag overwrap
- Size: 100mL bag
- Lot Number 24070381
- Expiration Date: Sep-2025
Hikma’s direct customers nationwide were sent a notification about the recall on July 8, 2024. The communication made the following requests:
- Locate and remove any recalled product from all distribution
- Have the recalled products returned by way of Inmar Rx Solutions Inc., Hikma’s recall service provider.
- Notify all direct retail customers who may have been distributed products from the affected lot.
- Following the transition to a consumer/user level recall, customers at medical-level facilities should identify and remove any recalled products from any distribution and have the items returned.
Consumers may direct recall inquiries to Hikma or Inmar using the contact information provided in the FDA communication.
Anyone experiencing health problems while using the drug product should consult their medical provider.
As the FDA continues to monitor this recall, consumers are encouraged to report any adverse reactions or quality issues to the agency’s MedWatch Adverse Event Reporting program.
Have you or a loved one suffered an adverse health outcome that can be traced to a mislabeled or mis-used medical drug? After a traumatic and potentially life-altering medical event, your case warrants serious attention, and you deserve maximum compensation. Our experienced attorneys at TruLaw are prepared to help you take the steps necessary to hold negligent parties responsible and secure the funds necessary for your recovery. Contact us today or try out our free Instant Case Evaluation ℠ to learn more.