FDA Recalls HYDROmorphone Injection Cassettes Due to Sterility Concerns
SCA Pharmaceuticals recalls 256 units of HYDROmorphone HCl injection in Grey CADD Cassettes nationwide due to lack of assured sterility. The affected lot is #1223049529 with expiration date 01/03/24.
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 involving a sterility assurance issue with an injectable drug product. While no illnesses or injuries have been reported, a sterility failure poses a significant risk of infection from contamination if the product is administered to patients, making it a risk-of-harm product where injury has not yet been reported.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling HYDROmorphone HCl 20 mg/100 mL injections in Grey CADD Cassettes (NDC 70004-0300-63) because the manufacturer cannot assure that the product meets sterility standards. The recall affects 256 cassettes distributed nationwide.
The specific lot affected is #1223049529 with an expiration date of 01/03/24. A lack of assurance of sterility in injectable products means there is a potential risk that the product could be contaminated with bacteria or other microorganisms that could cause infections if administered to patients.
Healthcare facilities and pharmacies that received this product should cease use and contact SCA Pharmaceuticals or the FDA regarding proper handling and return of any remaining stock.
The recalled product
- Product
- HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063
- Manufacturer
- SCA Pharmaceuticals, LLC
- Hazard
- contamination
- 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 (2)
- Lot #: 1223049529
- Exp 01/03/24
Distribution
Distributed nationwide across the United States.
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