Drug product
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
D-0190-2017
Product summary
- Event
- Event 75745
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2889 bags
- Official record key
drug-enforcement:D-0190-2017
Official wording
Reason: Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Code information: Lot: 8942 BUD: 2/19/2017, Lot: 9207 BUD: 4/17/2017
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility