Hydromorphone Sodium Chloride Injection (SCA Pharmaceuticals) – Sterility Concerns (2023)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-16, Bar Code 70004030316
Brand
SCA Pharmaceuticals, LLC
Lot Codes / Batch Numbers
Lot #: 1223048357 Exp 11/15/23, 1223048461 EXP 11/20/23, 1223048486 EXP 11/21/23, 1223048694 EXP 12/01/23, 1223048865 EXP 12/06/23, 1223048967 EXP 12/11/23, 1223049098 EXP 12/15/23, 1223049133 EXP 12/19/23, 1223049175 EXP 12/20/23, 1223049268 EXP 12/25/23, 1223049457 EXP 01/01/24, 1223049561 EXP 01/04/24, 1223049604 EXP 01/05/24, 1223049648 EXP 01/09/24, 1223049870 EXP 01/17/24, 1223049942 EXP 01/19/24, 1223049973 EXP 01/23/24, 1223050060 EXP 01/25/24
Products Sold
Lot #: 1223048357 Exp 11/15/23; 1223048461 EXP 11/20/23; 1223048486 EXP 11/21/23; 1223048694 EXP 12/01/23; 1223048865 EXP 12/06/23; 1223048967 EXP 12/11/23; 1223049098 EXP 12/15/23; 1223049133 EXP 12/19/23; 1223049175 EXP 12/20/23; 1223049268 EXP 12/25/23; 1223049457 EXP 01/01/24; 1223049561 EXP 01/04/24; 1223049604 EXP 01/05/24; 1223049648 EXP 01/09/24; 1223049870 EXP 01/17/24; 1223049942 EXP 01/19/24; 1223049973 EXP 01/23/24; 1223050060 EXP 01/25/24;
SCA Pharmaceuticals, LLC is recalling HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill due to Lack of Assurance of Sterility. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026