FDA Recall D-0635-2024
Hikma Pharmaceuticals USA Inc. · Cherry Hill, NJ
Class I — life-threatening Ongoing 675 days on record
Product
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
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)
Recall record
- Recall number
D-0635-2024- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- OH and PR
- Recall initiated
- 2024-07-08
- Classified by FDA Center
- 2024-08-16
- FDA published
- 2024-08-28
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Firm location
- Cherry Hill, NJ
Drug identification
- Brand name(s)
- ACETAMINOPHEN
- Generic name(s)
- ACETAMINOPHEN
- Manufacturer(s)
- Hikma Pharmaceuticals USA Inc.
- NDC(s)
0143-9386- Route(s)
- INTRAVENOUS
Operational response
A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.
For the official FDA enforcement record, see FDA's Recall Search.