HYDROmorphone Injectable Syringes Recalled for Lack of Sterilization Validation
Central Admixture Pharmacy Services is recalling 5,259 HYDROmorphone injectable syringes nationwide due to lack of validation data for sterilization, raising concerns about product sterility assurance.
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 a high-risk injectable drug product with potential sterility assurance issues due to missing validation data for sterilization. No illnesses or injuries have been reported. Per the rubric, when a hazard is theoretical and no injuries are documented, the maximum score is 3.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling HYDROmorphone 1 mg/mL in 0.9% sodium chloride injectable syringes nationwide. The recall involves approximately 5,259 syringes with multiple lot numbers, each with expiration dates ranging from July through September 2023.
The product is being recalled due to lack of validation data for sanitization cycles, which creates insufficient assurance of sterility. For injectable medications, sterility is a critical requirement.
Anyone who may have received this product should contact their healthcare provider. Healthcare facilities should identify and quarantine any affected lots and follow manufacturer instructions for return or replacement.
The recalled product
- Product
- HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2012-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable
- Affected units
- 5,259
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 (20)
- Lot: 17-270534
- Exp. 7/16/2023
- 17-270705
- Exp. 7/18/2023
- 17-270782
- 17-270797
- 17-270798
- Exp. 7/19/2023
- 17-270968
- Exp. 7/23/2023
- 17-271105
- 17-271154
- Exp. 7/25/2023
- 17-271251
- Exp. 7/26/2023
- 17-271330
- Exp. 7/27/2023
- 17-271418
- Exp. 7/30/2023
- 17-271746
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 recalled by Central Admixture Pharmacy Services Inc 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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