Recalls / Class II
Class IID-0776-2023
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
- Affected lot / code info
- 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
Why it was recalled
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.
Recalling firm
- Firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1015 Bowles Ave, N/A, Fenton, Missouri 63026-2394
Distribution
- Quantity
- 3,232 syringes
- Distribution pattern
- Product was distributed in Missouri.
Timeline
- Recall initiated
- 2023-05-09
- FDA classified
- 2023-05-31
- Posted by FDA
- 2023-06-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0776-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.