D-0596-2018 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 21, 2018
- Initiation Date
- February 7, 2018
- Termination Date
- August 7, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53600 vials
Product Description
Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01
Reason for Recall
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Distribution Pattern
Nationwide in the USA
Code Information
Lots # 691853F, EXP. 9/1/2018; 700753F, EXP. 10/1/2018.