FDA Recalls HYDROmorphone Syringes for Sterility Assurance Issue
Central Admixture Pharmacy Services has recalled approximately 398 HYDROmorphone in dextrose 5% injectable syringes nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider immediately.
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: FDA Class II classification indicates potential for serious health consequences. The hazard—lack of assurance of sterility in an injectable medication—represents risk of harm to patients. No illnesses or deaths have been reported, placing this at High rather than Severe.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling HYDROmorphone in dextrose 5% (0.1 mg/mL) 5 mL syringes due to lack of assurance of sterility. The recalled product is NDC 71286-2012-1 from lot 17-275730 with an expiration date of October 9, 2023.
Sterility is critical for injectable medications to prevent serious infections and complications. The manufacturer could not provide adequate assurance that the product meets required sterility standards.
Approximately 398 syringes were distributed nationwide in the United States. Patients who have received this product should contact their healthcare provider or pharmacy immediately.
Patients should not use the recalled product. Healthcare facilities and pharmacies should cease distribution of lot 17-275730 and contact their supplier for instructions on return or destruction.
The recalled product
- Product
- HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 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 narcotic
- Hazard
- sterility-assurance
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: 17-275730
- Exp 10/09/2023
Distribution
Distributed nationwide across the United States.
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