Drug product
HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
D-0875-2017
Product summary
- Event
- Event 77314
- Status
- Terminated
- Classification
- Class II
- Quantity
- 87 bags
- Official record key
drug-enforcement:D-0875-2017
Official wording
Reason: Lack of assurance of sterility: Product bags leaking at seam.
Code information: LOT # 20170505@23, 20170505@28, Use By: 08/03/17
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility