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.

FDA recall notice · announced September 27, 2017 · Pharmedium Services

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.

Notes

Distribution: Nationwide
Lot/code information: Lots: 170850012C and 170850020C Exp. 06/25/17
Quantity: 590 bags
Status: Terminated
Products in this recall event:
- Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 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, Clevelan (D-1166-2017)
- 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, Clevelan (D-1165-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.