D-1165-2017 Class II Terminated
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