D-1165-2017 Class II Terminated

Recalled by PharMedium Services, Llc — Sugar Land, TX

Recall Details

Product Type
Drugs
Report Date
September 27, 2017
Initiation Date
April 6, 2017
Termination Date
January 13, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
590 bags

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.

Distribution Pattern

Nationwide

Code Information

Lots: 170850012C and 170850020C Exp. 06/25/17