Drug product
HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44
D-1084-2020
Product summary
- Event
- Event 85212
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1840 units
- Official record key
drug-enforcement:D-1084-2020
Official wording
Reason: Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Code information: 193510022D 3/17/2020 193510023D 3/17/2020 193580012D 3/25/2020 193600013D 3/26/2020 193640016D 3/30/2020 193530020D 3/19/2020 193540023D 3/22/2020 193540026D 3/22/2020
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Sterility assurance
lack of sterility