Drug product
Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40
D-0080-2018
Product summary
- Event
- Event 78503
- Status
- Terminated
- Classification
- Class II
- Quantity
- 499 syringes
- Official record key
drug-enforcement:D-0080-2018
Official wording
Reason: Superpotent drug: out of specification result for potency
Code information: Lot#: 172820134M, Exp 01/18
Distribution pattern: CA, IL
Derived failure modes
-
Potency or specification failure
Superpotent