Recall record at a glance
| Official record | D-1825-2015 |
|---|---|
| Category | Drug Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Pharmedium Services, LLC |
| Report date | Sep 30, 2015 |
| Recall initiation date | Jan 28, 2015 |
| Quantity | 663 bags |
| Location | Lake Forest, IL, United States |
Official product description
Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-107-50
Why the product was recalled
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Distribution information
Nationwide
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.