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Pain Injections Recalled
Central Admixture Pharmacy Services Inc. is recalling nearly 5000 hydromorphone injections because of a lack of assurance of sterility. Specifically, the injections lack validation data for sanitization cycles, according to recall announcements added to the US Food and Drug Administration (FDA) Enforcement Report website over the past week.
The recall affects the following products, which were distributed throughout the United States by CAPS, Central Admixture Pharmacy Services Inc., San Diego, California:
- hydromorphone in 0.9% sodium chloride, 6 mg/30 mL (0.2 mg/mL), 30-mL syringe (NDC 71286-2010-1), from lots 17-270603 (Exp. 7/17/23), 17-270802 (Exp. 7/19/23), 17-271073 (Exp. 7/24/23), 17-271129 (Exp. 7/25/23), 17-271254 (Exp. 7/26/23), 17-271953 (Exp. 8/8/23), 17-272022 (Exp. 8/9/23), 17-272295 (Exp. 8/14/23), 17-272616 (Exp. 8/20/23), 17-273357 (Exp. 8/31/23), and 17-273501 (Exp. 9/4/23); and
- hydromorphone in dextrose 5%, 3 mg/30 mL (0.1 mg/mL), 30-mL syringe (NDC 71286-2013-2), from lots 17-270675 and 17-270683 (Exp. 7/18/23), 17-271147 and 17-271119 (Exp. 7/25/23), 17-271339 (Exp. 7/27/23), 17-271679 (Exp. 8/2/23), 17-272202 (Exp. 8/10/23), 17-272241 (Exp. 8/13/23), 17-272375 (Exp. 8/15/23), 17-272783 (Exp. 8/22/23), 17-273438 and 17-273431 (Exp. 9/3/23), 17-273615 (Exp. 9/5/23), and 17-273789 (9/7/23).
Central Admixture Pharmacy Services voluntarily initiated the recalls on July 17, 2023. The FDA designated them Class II on August 3, 2023. Per the recall classification, use of the injections could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Hydromorphone is a prescription narcotic used to relieve moderate to severe pain.