Drug product
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
D-0596-2018
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 79114
- Status
- Terminated
- Classification
- Class I
- Quantity
- 53600 vials
- Official record key
drug-enforcement:D-0596-2018
Official wording
Reason: Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Code information: Lots # 691853F, EXP. 9/1/2018; 700753F, EXP. 10/1/2018.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.