Drug product
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA. NDC: 0703-0018-01
D-1080-2017
Product summary
- Event
- Event 77836
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,300 vials
- Official record key
drug-enforcement:D-1080-2017
Official wording
Reason: Presence of Particulate Matter: Silicone oil
Code information: Lot #: 560053F, Exp. 01AUG2017
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter