PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: September 27, 2017 Initiated: April 6, 2017 #D-1165-2017

Product Description

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.

Details

Recalling Firm
PharMedium Services, Llc
Units Affected
590 bags
Distribution
Nationwide
Location
Sugar Land, TX

Frequently Asked Questions

What product was recalled?
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.. Recalled by PharMedium Services, Llc. Units affected: 590 bags.
Why was this product recalled?
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 27, 2017. Severity: Moderate. Recall number: D-1165-2017.