Reported May 8, 2024 · Completed
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by:…
Hikma Injectables USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hikma Injectables USA Inc · 36 Stults Rd · Dayton, NJ · 08810-1540
Is this the product you have?
- Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only
- Compounded by
Hikma Injectables USA Inc. 2 Esterbrook LaneCherry HillNJ 08003
- Distributed by
Hikma Injectables USA Inc. 36 Stults RoadDaytonNJ 08810NDC 63037-100-05
- Lot codes and dates
Lot #: CH0324001Exp. Date 3/4/2025
- Amount recalled
- 1,895 bags
Where it was sold
- Nationwide
Why it was recalled
Labeling: Wrong Barcode
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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