PlainRecordsAcetaminophen Injection…
- Reason
- 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)
- Status
- Ongoing
- Distribution
- OH and PR
- Enforcement report date
- Aug. 28, 2024
- Risk class
- Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
- Status
- Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Hikma Pharmaceuticals USA Inc.
- 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
- 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)
- Distribution pattern
- OH and PR
- Quantity
- 31,400 bags
- Codes and lots
- Lot #24070381; Exp. 09/30/2025
- Recall started
- July 8, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall number
- D-0635-2024
What the record says about this drug
A simplified drawing of a vial, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“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)”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, FDA enforcement report, 2024-08-28. The caption is the record's own words.
A generic vial, not the product. The mark follows the record's own words (a question mark, where used, stands for a lack of assurance the record names, not for anything found).
If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.
Distributed in (FDA's record): Ohio Puerto Rico
This recall among the others
- FDA's enforcement report came 51 days after the firm started the recall. For half of the 311 FDA drug recall events reported in 2024 with a start date, it took 27 days or fewer (by year).
- Hikma Pharmaceuticals USA: 5 other recalls or notices on this site in the three years before this one (from Aug. 29, 2021).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? Medicine recall: what to do · How to read this record
Source: FDA · Drug enforcement report, recall number D-0635-2024. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record D-0635-2024, Aug. 28, 2024. "Acetaminophen Injection." PlainRecords, https://plainrecords.com/recall/drug/d-0635-2024/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections