HYDROmorphone Injectable Recalled Due to Sterility Assurance Failure
SCA Pharmaceuticals is recalling HYDROmorphone HCl injections due to lack of assurance of sterility. Patients who received the affected lot should contact their healthcare provider.
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 drug where the hazard is failure to assure sterility—a risk-of-harm scenario. No illnesses or injuries are reported in the source. Per the rubric, Class II recalls without reported injury and where the hazard remains theoretical score as High (3).
Plain-English summary
SCA Pharmaceuticals, LLC is recalling HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection. The recalled product is supplied as a 25 mL fill in a 30 mL syringe with a concentration of 1 mg/mL. The affected lot number is 1223048491 with an expiration date of 11/21/23, and the recall involves 399 syringes.
The recall was issued because the manufacturer cannot assure that the product meets sterility standards required for injectable medications. Injectables must be free from microbial contamination to prevent serious infections in patients receiving the medication.
The affected product was distributed nationwide throughout the United States. Patients who received this medication should contact their healthcare provider to discuss the recall and determine next steps for their care.
The recalled product
- Product
- HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable
- Affected units
- 399
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 (1)
- Lot #: 1223048491 Exp 11/21/23
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 recalled by SCA Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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