Drug product
Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-112-52.
D-1165-2017
Product summary
- Event
- Event 77856
- Status
- Terminated
- Classification
- Class II
- Quantity
- 590 bags
- Official record key
drug-enforcement:D-1165-2017
Official wording
Reason: Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Code information: Lots: 170850012C and 170850020C Exp. 06/25/17
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.