Recall record at a glance
| Official record | D-0190-2017 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Cantrell Drug Company |
| Report date | Dec 21, 2016 |
| Recall initiation date | Nov 18, 2016 |
| Quantity | 2889 bags |
| Location | Little Rock, AR, United States |
Official product description
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL* Bag, Epidural Use Only, Single-Dose Bag, Hospital/Office Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-080-75
Why the product was recalled
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Distribution information
Nationwide
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Press Release.
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.
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