The FDA and manufacturer Hikma Pharmaceuticals PLC have announced an immediate recall of Acetaminophen injections due to mislabeling. Acetaminophen is the active ingredient in Tylenol and many other over-the-counter pain relief medications. Healthcare professionals typically administer the injections in a medical facility. However, both healthcare workers and patients must be aware of this recall and ensure that each bag of solution is thoroughly examined before administration.
As of the writing of this notice, Hikma Pharmaceuticals PLC has reportedly received one report of an adverse event related to this recall.
SUMMARY
Date of Recall:
Announced: July 22, 2024
Public Notification: July 22, 2024
Name(s) of Drug:
Acetaminophen Injection 1,000 per 100 mL (10mg/mL) 100 mL
Company Name:
Hikma Pharmaceuticals PLC
Drug Indication:
Pain
Product Description
Acetaminophen injections are available by prescription only and are distributed nationwide to medical facilities. Each bag contains 100 mL of solution and 1,000 mg of acetaminophen. The bags are contained within silver packaging that is labeled with the drug information. Inside is a clear IV bag that contains another label.
Both labels must be inspected before administration.
Reason for Recall
Hikma Pharmaceuticals PLC has received one report of an adverse event after a patient received an incorrect medication. The drug’s exterior packaging is correctly labeled. However, the IV bag contained within the packaging is another medication called Dexmedetomidine HCL (400mcg/100mL). If administered, a patient may receive an incorrect medication and miss the ordered drug.
Impacts
Consumers who receive the incorrect drug rather than the ordered Acetaminophen will miss their dose of pain relief medication. This may result in continued or worsening pain.
In addition, they will receive an infusion of Dexmedetomidine HCL, a drug used to sedate patients prior to certain procedures. This could lead to symptoms such as:
- Sedation
- Bradypnea (slow breathing)
- Bradycardia (slow heart rate)
- Hypertension (high blood pressure)
- Hypotension (low blood pressure)
These effects may lead to poor outcomes, including loss of life.
Recall Product Information
Consumers who are set to receive an IV (intravenous) injection of Acetaminophen should ask the healthcare provider to carefully double-check both packaging bags. You can also ask to verify the label yourself prior to receiving the injection. Healthcare providers should remain diligent in confirming the label on both interior and exterior packaging to ensure the correct infusion is administered.
All facility stock must be thoroughly examined and affected stock removed immediately.
| NDC | Product Name and Strength | Size | Lot Number | Expiration Date |
| 0143-9386-10 0143-9386-01, Individual bag overwrap | Hikma brand Acetaminophen Injection USP, 1,000 mg per 100 mL (10 mg/mL) | 100mL bag | 24070381 | Sep-2025 |
www.fda.gov
Have you found that you are in possession of drugs included in the recall? Here’s what you should do:
Consumers
- Ask your healthcare provider to replace the infusion with one not included in the recall.
- Seek immediate medical attention if you have received the recalled medication.
- Monitor your health for any adverse symptoms and seek medical attention if you have concerns.
- If you are experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- If you have questions, contact the manufacturer using the following information.
| 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-6pm (EST) | Recall related inquires |
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock included in the recall.
- Notify facilities of recalled batches that they have already or will receive.
- If you have questions, contact the manufacturer using the following information.
| 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-6pm (EST) | Recall related inquires |
| Inmar Rx Solutions, Inc. (Hikma 3rd Party Recall Service Provider) | Mail to: Inmar RX Solutions, Attention recall Coordinator, 3845 Grand Lakes Way, Grand Prairie, TX 75050 (E): HikmaEvent@Inmar.com (F): 1-817-868-5362 | Product Returns |
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and consider removing stock included in the warning.
- Notify facilities of recalled batches that they have already or will receive.
- If you have questions, contact the manufacturer using the following information.
| 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-6pm (EST) | Recall related inquires |
| Inmar Rx Solutions, Inc. (Hikma 3rd Party Recall Service Provider) | Mail to: Inmar RX Solutions, Attention recall Coordinator, 3845 Grand Lakes Way, Grand Prairie, TX 75050 (E): HikmaEvent@Inmar.com (F): 1-817-868-5362 | Product Returns |
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
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Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!
