FDA recalls HYDROmorphone injectable syringes for sterility assurance defect
The FDA is recalling HYDROmorphone injectable syringes from Central Admixture Pharmacy Services Inc. due to lack of sterility assurance. Approximately 1,190 syringes nationwide are affected.
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 recall for a sterility defect in compounded injectable medication. No illnesses reported; however, lack of sterility in injectable products poses a direct risk of infection, meeting the 'High' severity criterion for risk-of-harm products.
Plain-English summary
The U.S. Food and Drug Administration is recalling HYDROmorphone injectable in 0.9% sodium chloride (6 mg/30 mL, 0.2 mg/mL) supplied in 30 mL syringes from Central Admixture Pharmacy Services Inc. The recall is due to lack of assurance of sterility in the affected product.
Approximately 1,190 30 mL syringes have been distributed nationwide in the United States. The recall involves three manufacturing lots: Lot 17-275680 (expiring 10/8/2023), Lot 17-275945 (expiring 10/13/2023), and Lot 17-276094 (expiring 10/17/2023).
HYDROmorphone is a prescription opioid medication. Healthcare providers and facilities should verify whether they have received product from these affected lots.
The recalled product
- Product
- HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Compounded Injectable
- Hazard
- sterility
- 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 (6)
- Lot:17-275680
- Exp. 10/8/2023
- 17-275945
- Exp. 10/13/2023
- 17-276094
- Exp. 10/17/2023
Distribution
Distributed nationwide across the United States.
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