HYDROmorphone Injectable Syringes Recalled Over Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 1,190 units of HYDROmorphone injectable syringes nationwide due to lack of sterility assurance. Patients using affected lots should contact their healthcare provider.
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 an injectable medication with sterility assurance deficiency. While no illnesses or injuries have been reported, this constitutes a risk-of-harm situation for a critical-use injectable product where sterility is essential.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling HYDROmorphone in 0.9% sodium chloride injectable syringes (10 mg/50 mL) distributed nationwide. The recall affects 1,190 units across multiple lots with expiration dates in October 2023.
The manufacturer has determined that these syringes cannot be assured to meet sterility requirements. Sterility is a critical safety attribute for injectable medications, and any deficiency in sterility assurance poses a potential risk to patients.
Patients who have received syringes from the affected lots should contact their healthcare provider or pharmacy immediately. Healthcare facilities should identify patients who may have received affected product and take appropriate action.
The recalled product
- Product
- HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Prescription Injectable
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 (7)
- Lot:17-275728
- Exp. 10/9/2023
- 17-275791
- 17-275803
- Exp. 10/10/2023
- 17-276244
- Exp. 10/20/2023.
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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