Elevated risk U.S. Food and Drug Administration

Hikma Acetaminophen Injection 1,000 mg per 100 mL 100 mL recall: Potential presence of Dexmedetomidine HCL Injection (400mcg/100mL) inside

Recall published 2+ years ago

Potential presence of Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL).

Hikma Prescription & OTC drugs — recalled prescription & otc drugsHikma Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Drug safety concern

This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

What the notice says: If the provider does not identify the drug inside the acetaminophen overwrap as dexmedetomidine and administers the drug to a patient, there are multiple potential adverse outcomes that may result including varying degrees of sedation, bradypnea, bradycardia, hypertension, and hypotension or more serious and potentially life-threatening outcomes.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Published
July 22, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Hikma
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mL

What the company announced

FOR IMMEDIATE RELEASE - London, July 22, 2024 – Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA, Inc. is extending its voluntary recall of one lot (listed below) of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) to the consumer/user level. The product is being recalled due to the potential presence of a bag labelled Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL).

If the provider does not identify the drug inside the acetaminophen overwrap as dexmedetomidine and administers the drug to a patient, there are multiple potential adverse outcomes that may result including varying degrees of sedation, bradypnea, bradycardia, hypertension, and hypotension or more serious and potentially life-threatening outcomes. To date, Hikma has received one report of an adverse event.

On July 8, 2024, Hikma voluntarily initiated a retail level recall of Acetaminophen Injection 1000mg/100mL(10mg/mL), lot 24070381.

The lot being recalled was manufactured on 3/19/2024.

Acetaminophen Injection is a sterile, nonpyrogenic ready-to-use solution, available in IV bags for intravenous infusion. Each 100 mL contains 1,000 mg acetaminophen, USP, 193 mg anhydrous citric acid, USP, sodium chloride, USP (tonicity agent) and water for injection. pH may be adjusted with hydrochloric acid and/or sodium hydroxide. Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older and the reduction of fever in adult and pediatric patients.

The affected lot number and expiration date being recalled is as follows:

  • NDC:: 0143-9386-10 0143-9386-01, Individual bag overwrap · Product Name and Strength: Hikma brand Acetaminophen Injection USP, 1,000 mg per 100 mL (10 mg/mL) · Size: 100mL bag · Lot Number: 24070381 · Expiration Date: Sep-2025

The product can be identified by name and NDC and lot code, which are clearly stated on the overwrap of the product label, along with Hikma Pharmaceuticals USA Inc. name and address. Images of the labels are included below:

The product was distributed to Hikma’s direct customers nationwide. Hikma notified its direct customers as part of the recall on July 8, 2024, asking them to locate and remove the recalled product from distribution channels and return the recalled lot to Hikma’s recall service provider (Inmar Rx Solutions Inc.). Hikma also requested the direct customers to notify their direct retail customers to whom this affected product lot was distributed. Hikma is now extending the recall to the consumer/user level and asking customers at medical level facilities to locate and remove the recalled product from their channels and return the recalled lot.

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

Consumers with questions regarding this recall can contact Inmar by telephone at 877-890- 0765 (Monday through Friday, 9 a.m. to 5 p.m. ET) or by email at [email protected] .

  • Hikma Contact:: Hikma Pharmaceuticals USA Inc, – Customer Service · Contact Information: (P): (800) 631-2174 (E): [email protected] (F): (732) 542-0940 Hours of operation, M-F: 8:00am-6pm (EST) · Areas of Support: Recall related inquires
  • Hikma Contact:: Inmar Rx Solutions, Inc. (Hikma 3rd Party Recall Service Provider) · Contact Information: Mail to: Inmar RX Solutions, Attention recall Coordinator, 3845 Grand Lakes Way, Grand Prairie, TX 75050 (E): [email protected] (F): 1-817-868-5362 · Areas of Support: 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.

Complete and submit the report Online

Regular Mail or Fax: Download form 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 product lot recall is being made with the FDA’s knowledge.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 24070381
  • 1000mg/100mL

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • Sep-2025

NDC number

On the carton and again on the bottle or blister label.

  • 0143-9386-10

Package size

Match the net weight or the piece count on the front of the pack.

  • 000 mg
  • 100 mL
  • 10 mg
  • 1000 mg
  • 193 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Hikma — This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

  1. Check the lot number on your pack against the codes listed above.
  2. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  3. Keep the carton; the lot number is often printed only on the outer pack.
  4. Report side effects you think the product caused to FDA MedWatch.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Hikma Pharmaceuticals PLC — Consumers: Hikma Pharmaceuticals USA Inc., (800) 631-2174, [email protected] — Media: Steve Weiss US Communications and Public Affairs, +1 732-788-8279, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Hikma prescription & otc drugs recalled?

Potential presence of Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL). If the provider does not identify the drug inside the acetaminophen overwrap as dexmedetomidine and administers the drug to a patient, there are multiple potential adverse outcomes that may result including varying degrees of sedation, bradypnea, bradycardia, hypertension, and hypotension or more serious and potentially life-threatening outcomes.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 24070381, 1000mg/100mL; best-by date Sep-2025. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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