Drug product
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-10
D-0196-2017
Product summary
- Event
- Event 75745
- Status
- Terminated
- Classification
- Class II
- Quantity
- 93 vials
- Official record key
drug-enforcement:D-0196-2017
Official wording
Reason: Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Code information: Lot: 163941
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility