Reported Jun 7, 2023 · Ongoing
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation…
SSM Health Care St. Louis dba SSM St. Clare Health Center
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SSM Health Care St. Louis DBA SSM St. Clare Health Center · 1015 Bowles Ave · Fenton, MO · 63026-2394
Is this the product you have?
- 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
- NDC60652-0600-2
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 20230222-45AB24, BUD: 8/21/2023 2 Lot #: 20230110-058361, BUD: 7/9/2023 3 Lot #: 20221208-0F5483, BUD: 6/6/2023 4 Lot #: 20221109-45BA60, BUD: 5/8/2023 5 Lot #:20220929-523FD5, BUD: 3/28/2023 6 Lot#: 20220914-5D5AE0, BUD: 3/13/2023 7 Lot #: 220502-024, BUD: 10/29/2022 8 Lot #: 220510-035, BUD: 11/6/2022 9 Lot #: 220526-015, BUD: 11/22/2022 10 Lot#: 220811-010, BUD: 2/7/2023 - Amount recalled
- 3,232 syringes
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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