D-1082-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 16, 2017
- Initiation Date
- July 26, 2017
- Termination Date
- May 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56,340 vials
Product Description
Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.
Reason for Recall
Presence of Particulate Matter: Silicone oil
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 560103F, Exp. 01AUG2017