Drug product
Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05
D-1017-2017
Product summary
- Event
- Event 77770
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1017-2017
Official wording
Reason: Lack of Assurance of Sterility; product has the potential to leak.
Code information: Lot: 20170508@75 BUD: 8/6/2017
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility