Agency classClass IIOur severity:High FDA (Drugs)·D-0031-2024·Announced 2023-10-11

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.

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: 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.

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.

See all 32 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services Inc

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Same hazard · lack of sterility