PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 9, 2023 Initiated: July 17, 2023 #D-1052-2023

Product Description

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

Reason for Recall

Lack of assurance of sterility: Lack of validation data for sanitization cycles

Details

Units Affected
3824 bags
Distribution
Nationwide in the USA
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by Central Admixture Pharmacy Services Inc. Units affected: 3824 bags.
Why was this product recalled?
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Which agency issued this recall?
This recall was issued by the FDA Drug on August 9, 2023. Severity: Moderate. Recall number: D-1052-2023.