HYDROmorphone Syringes Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 4,550 syringes of HYDROmorphone due to lack of assurance of sterility. The product was distributed nationwide.
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 of injectable medication due to lack of sterility assurance. No reported hospitalizations or significant injuries. Classified as a risk-of-harm product without reported injury, matching the rubric criterion for High (3).
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling HYDROmorphone 15 mg/30 mL in 30 mL syringes (NDC 71286-2011-1) distributed nationwide. The recall affects approximately 4,550 syringes.
The recall is due to lack of assurance of sterility. HYDROmorphone is an opioid pain medication typically administered intravenously. Injectable medications must maintain strict sterile conditions to prevent contamination and potential infection.
The affected lot numbers are: 17-275315 (expires 10/3/2023), 17-275466 (expires 10/4/2023), 17-275477 (expires 10/4/2023), 17-276102 (expires 10/17/2023), and 17-276221 (expires 10/19/2023). The product was manufactured by Central Admixture Pharmacy Services Inc, located at 7935 Dunbrook Road, Suite C, San Diego, CA 92126.
Patients and healthcare providers should cease use of affected syringes and consult their healthcare provider regarding further guidance.
The recalled product
- Product
- HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable opioid
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 (9)
- Lot:17-275315
- Exp.10/3/2023
- 17-275466
- 17-275477
- Exp.10/4/2023
- 17-276102
- Exp. 10/17/2023
- 17-276221
- Exp. 10/19/2023
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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