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
Reported: June 7, 2023 Initiated: May 9, 2023 #D-0776-2023
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Units Affected
- 3,232 syringes
- Distribution
- Product was distributed in Missouri.
- Location
- Fenton, MO
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SSM Health Care St. Louis DBA SSM St. Clare Health Center. Units affected: 3,232 syringes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 7, 2023. Severity: Moderate. Recall number: D-0776-2023.
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