Hydromorphone Syringe Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services Inc. is recalling hydromorphone syringes due to lack of assurance of sterility. The recall affects 274 syringes 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 with no reported illnesses, injuries, or deaths. The hazard is a quality assurance issue (lack of sterility assurance) without confirmed contamination or reported harm, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling HYDROmorphone in dextrose 5% (0.1 mg/mL), 30 mL syringes due to lack of assurance of sterility. The product is a prescription injectable medication used for pain management.
The recall was initiated because the manufacturer cannot assure that the syringes meet sterility standards. This applies to lot numbers 17-275266 (expiration 10/2/2023) and 17-275666 (expiration 10/8/2023). The product is identified by NDC 71286-2013-2.
The affected product was distributed nationwide in the USA. A total of 274 syringes are subject to this recall. Healthcare facilities and patients who have received this medication should contact Central Admixture Pharmacy Services Inc. or their healthcare provider for further instructions. The recalled product should not be used.
The recalled product
- Product
- HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2
- Manufacturer
- Central Admixture Pharmacy Services Inc
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 (4)
- Lot:17-275266
- Exp. 10/2/2023
- 17-275666
- Exp. 10/8/2023.
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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