D-0132-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 7, 2018
- Initiation Date
- October 19, 2018
- Termination Date
- May 6, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 syringes
Product Description
Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Reason for Recall
Lack of assurance of sterility
Distribution Pattern
U.S.A. nationwide.
Code Information
Lot # 8/8/18 0200 15-21070S, Exp 11/06/2018