Drug product
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50
D-1081-2017
Product summary
- Event
- Event 77836
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,009 vials
- Official record key
drug-enforcement:D-1081-2017
Official wording
Reason: Presence of Particulate Matter: Silicone oil
Code information: Lot #: 56260DD, Exp. 01AUG2017
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter