FDA Recalls Hydromorphone Injections Due to Discontinued Quality Assurance Program
The FDA is recalling Hydromorphone HCl 10 mg injections due to the manufacturer's discontinuation of its quality assurance program. The product, distributed in Missouri, may not meet standards for strength, purity, and identity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall due to CGMP deviations (discontinued quality program). It qualifies as a risk-of-harm product where injury has not yet been reported, since no illnesses or injuries have been reported and the hazard is theoretical rather than based on confirmed defects.
Plain-English summary
Hydromorphone HCl 10 mg in 0.9% Sodium Chloride, supplied in 50 mL syringes (0.2 mg/mL), manufactured by SSM Health Care St. Louis DBA SSM St. Clare Health Center, is being recalled.
The FDA issued this Class II recall because the manufacturer discontinued its quality assurance program. Without this program, the FDA cannot assure the product meets specifications for identity, strength, quality, and purity as represented.
Approximately 3,232 syringes distributed in Missouri are affected. Multiple lot numbers with specific beyond-use dates are included in this recall.
The recalled product
- 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
- Manufacturer
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Category
- Drug — Injectable / Opioid
- Hazard
- identity-uncertainty
- strength-uncertainty
- purity-uncertainty
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution scope not specified by the agency.
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