Drug product
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2
D-0776-2023
Product summary
- Event
- Event 92395
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,232 syringes
- Official record key
drug-enforcement:D-0776-2023
Official wording
Reason: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Code information: Lot #: 20230222-45AB24, BUD: 8/21/2023; Lot #: 20230110-058361, BUD: 7/9/2023; Lot #: 20221208-0F5483, BUD: 6/6/2023; Lot #: 20221109-45BA60, BUD: 5/8/2023; Lot #:20220929-523FD5, BUD: 3/28/2023; Lot#: 20220914-5D5AE0, BUD: 3/13/2023; Lot #: 220502-024, BUD: 10/29/2022; Lot #: 220510-035, BUD: 11/6/2022; Lot #: 220526-015, BUD: 11/22/2022; Lot#: 220811-010, BUD: 2/7/2023
Distribution pattern: Product was distributed in Missouri.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations