Why it was recalled
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Product description
Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01
Lot numbers, UPCs & expiration codes
Lot #24070381; Exp. 09/30/2025
Where it was sold
OH and PR
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0635-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jul 8, 2024
- FDA report date
- Aug 28, 2024
- Quantity
- 31,400 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
Original FDA data
Every field from FDA enforcement report D-0635-2024, exactly as published.
Show all FDA fields
- City
- Cherry Hill
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94934
- Address
- 2 Esterbrook Ln
- Code information
- Lot #24070381; Exp. 09/30/2025
- Postal code
- 08003-4002
- Report date
- Aug 28, 2024
- Product type
- Drugs
- Recall number
- D-0635-2024
- Classification
- Class I
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Product quantity
- 31,400 bags
- Reason for recall
- Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01
- Distribution pattern
- OH and PR
- Recall initiation date
- Jul 8, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 16, 2024