Agency classClass IIOur severity:High FDA (Drugs)·D-1052-2023·Announced 2023-08-09

FDA Recalls Hydromorphone Injectable Solution Due to Sterility Validation Failure

The FDA has recalled 3,824 bags of hydromorphone injectable solution due to lack of validated sterilization processes. The affected product may not meet required sterility assurance standards.

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 an injectable opioid pharmaceutical. The hazard—lack of validated sterilization—represents a high-risk scenario for injectable products. However, the source reports no illnesses, hospitalizations, or confirmed contamination, placing the recall at the 'High' level per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling HYDROmorphone injectable solution (10 mg/50 mL, 0.2 mg/mL, 100 mL bags) distributed nationwide. The recall was initiated due to lack of assurance of sterility resulting from missing validation data for the sanitization cycles used in product preparation.

The affected product was distributed nationwide. The recall involves 3,824 bags with multiple lot numbers and expiration dates ranging from July 31, 2023 to September 11, 2023.

Healthcare facilities, hospitals, pharmacies, and healthcare providers who have received this product should discontinue use immediately. The product should not be dispensed to or administered to patients.

The recalled product

Product: HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-3
Manufacturer: Central Admixture Pharmacy Services Inc
Category: Drug — Injectable Opioid
Hazard: lack-of-sterility
sterilization-failure
Affected units: 3,824

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 (20)

Lot: 17-270599
17-270600
Exp. 7/17/2023
17-270785
Exp. 7/19/2023
17-270969
Exp. 7/23/2023
17-271116
17-271135
Exp. 7/25/2023
17-271242
Exp. 7/26/2023
17-271502
Exp. 7/31/2023
17-271561
17-271589
Exp. 8/1/2023
17-271672
Exp. 8/2/2023
17-271837

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 39 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 39 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services Inc

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Same hazard · lack of sterility