FDA Recalls Hydromorphone Syringes Over Sterility Assurance Issue
Central Admixture Pharmacy Services Inc is recalling 2,664 syringes of HYDROmorphone injectable solution (30 mg/30 mL) distributed nationwide. The recall was initiated due to lack of assurance of sterility.
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: This is an FDA Class II recall of injectable medication due to lack of sterility assurance. No illnesses or injuries are reported in the source text. Per the rubric, Class II recalls without reported harm and with theoretical contamination hazards score as High (3).
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL in 30 mL syringes (NDC 71286-2012-1). The recall affects 2,664 units distributed nationwide.
The company initiated this recall due to a lack of assurance of sterility in the product.
The affected lots include: 17-275339 (Exp. 10/3/2023), 17-275478 and 17-275488 (Exp. 10/4/2023), 17-275620 (Exp. 10/8/2023), 17-275730 (Exp. 10/9/2023), 17-275777 and 17-275793 (Exp. 10/10/2023), 17-275863 and 17-275958 (Exp. 10/11/2023), and 17-276027 (Exp. 10/16/2023).
Patients using this product or healthcare providers who have received it should discontinue use and contact Central Admixture Pharmacy Services Inc (7935 Dunbrook Road, Suite C, San Diego, CA 92126) or the FDA for guidance.
The recalled product
- Product
- HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable Opioid
- Hazard
- lack-of-sterility
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 (17)
- Lot: 17-275339
- Exp. 10/3/2023
- 17-275478
- 17-275488
- Exp. 10/4/2023
- 17-275620
- Exp. 10/8/2023
- 17-275777
- 17-275793
- Exp. 10/10/2023
- 17-275863
- 17-275958
- Exp. 10/11/2023
- 17-276027
- Exp. 10/16/2023
- 17-275730
- Exp. 10/9/2023.
Distribution
Distributed nationwide across the United States.
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