Hydromorphone Injection Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals recalls 1,023 syringes of Hydromorphone Injection nationwide due to lack of sterility assurance. No illnesses have been reported.
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 of an injectable pharmaceutical due to lack of sterility assurance. While no illnesses have been reported, non-sterile injectables pose inherent risk of serious infection. Per the rubric, this qualifies as a risk-of-harm product without reported injury, warranting a High severity score.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling Hydromorphone HCl Injection (10 mg/50 mL in 0.9% Sodium Chloride) distributed nationwide due to lack of assurance of sterility. A total of 1,023 affected syringes have been distributed with expiration dates from December 2023 to January 2024.
Patients and healthcare providers who have received this medication should stop using it and consult a healthcare provider about alternative treatments. No illnesses or injuries have been reported to date in association with this recall.
For more information, contact SCA Pharmaceuticals, LLC at 755 Rainbow Rd., Windsor, CT 06095, or visit the FDA's drug recall website.
The recalled product
- Product
- HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable Pharmaceutical
- Hazard
- lack-of-sterility-assurance
- infection-risk
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 (5)
- Lot#: 1223048801 Exp 12/04/23
- 1223049225 Exp 12/21/23
- 1223049264 Exp 12/25/23
- 1223049291 Exp 12/26/23
- 1223049726 exp 01/11/24
Distribution
Distributed nationwide across the United States.
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