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.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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.
Part of a larger recall action
This product is one of 32 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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