Drug product
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.
D-1082-2017
Product summary
- Event
- Event 77836
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56,340 vials
- Official record key
drug-enforcement:D-1082-2017
Official wording
Reason: Presence of Particulate Matter: Silicone oil
Code information: Lot #: 560103F, Exp. 01AUG2017
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter