SSM Health Care recalls specific hydrocodone syringes manufactured with CGMP deviations. These products may not meet required quality standards. Consumers should check product details and contact the manufacturer for guidance.
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.
SSM Health Care is recalling hydrocodone syringes that were produced with quality control issues. These syringes may not meet the required strength and purity standards, which could lead to unsafe medication use.
The manufacturer discontinued their quality control program, which means the syringes might not meet the required strength, purity, and quality standards. This could lead to inconsistent medication dosing or other safety issues.
Patients prescribed hydrocodone by a healthcare provider who received this specific syringe from SSM Health Care. Those using the product without a prescription are not affected.
Check for the product name 'HYDROmorphone HCl 10 mg in 0.9% Sodium Chloride, 50 mL syringe (0.2 mg/mL)' and the lot numbers listed in the recall notice. The product is prescription-only and sold through SSM Health Care.
Identify the product by checking the lot number and expiration date on the syringe label.
The recall indicates potential quality control issues, so it is not recommended to use these syringes. Contact SSM Health Care for further guidance.
Check the product details and contact SSM Health Care for instructions on what to do with the recalled syringes.
The recall states there may be quality control issues, but specific health risks are not detailed in the notice.
We’ve drafted a message you can send SSM Health Care to request your refund or repair — edit it as you like.
Subject: Recall D-0776-2023 — SSM Health Care SSM Health Care Hello, I own a SSM Health Care that is covered by recall D-0776-2023 from SSM Health Care. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.