Sterility Concerns Prompt Recall of Opioid Analgesics

Numerous fentanyl products are under a Class II recall because of a lack of assurance of sterility. According to recall announcements added to the US Food and Drug Administration (FDA) Enforcement Report website over the past week, the recalled drugs lacked validation data for sanitization cycles.

The recall affects the following fentanyl products, which were distributed throughout the United States by recalling firm Central Admixture Pharmacy Services Inc., San Diego, California:

• fentanyl in dextrose 5%, 300 mcg/30 mL (10 mcg/mL), 30-mL syringe (NDC 71286-2001-2), from lots 17-271144 (Exp. 7/25/23), 17-271354 (Exp. 7/27/23), 17-271681 (Exp. 8/2/23), 17-271990 (Exp. 8/7/23), and 17-272457 (Exp. 8/16/23);
• fentanyl, 1250 mcg/25 mL (50 mcg/mL), 30-mL syringe (NDC 71286-2003-7), from lots 17-270664 (Exp. 7/18/23), 17-270886 (Exp. 7/20/23), 17-270976 and 17-270989 (Exp. 7/23/23), 17-271335 (Exp. 7/27/23), 17-271572 (Exp. 8/1/23), 17-271747 (Exp. 8/3/23), 17-271808 (Exp. 8/6/23), 17-272023 (Exp. 8/9/23), 17-272203 (Exp. 8/13/23), 17-272718 (Exp. 8/21/23), 17-272797 (Exp. 8/22/23), 17-273157 (Exp. 8/29/23), 17-273507 (Exp. 9/4/23), 17-273766 (Exp. 9/7/23), 17-273862 (Exp. 9/10/23), 17-274052 (Exp. 9/12/23), and 17-274208 (Exp. 9/14/23);
• fentanyl, 100 mcg/2 mL (50 mcg/mL), 3-mL syringe (NDC 71286-2003-1), from lots 17-272549 (Exp. 8/15/23), 17-273342 (Exp. 8/31/23), and 17-274076 (Exp. 9/13/23);
• fentanyl, 250 mcg/5 mL (50 mcg/mL), 5-mL syringe (NDC 71286-2003-2), from lot 17-273267 (Exp. 8/31/23);
• fentanyl, 2500 mcg/50 mL (50 mcg/mL), 50-mL syringe (NDC 71286-2003-3), from lots 17-270771 (Exp. 7/19/23), 17-271134 (Exp. 7/25/23), 17-271577 (Exp. 8/1/23), 17-271745 (Exp. 8/3/23), 17-272026 (Exp. 8/9/23), 17-272345 (Exp. 8/15/23), 17-272615 (Exp. 8/20/23), and 17-273668 (Exp. 9/6/23);
• fentanyl, 2500 mcg/50 mL (50 mcg/mL), 100-mL bag (NDC 71286-2003-4), from lots 17-270533 (Exp. 7/16/23), 17-270580 and 17-270581 (Exp. 7/17/23), 17-270654 (Exp. 7/18/23), 17-271044 (Exp. 7/24/23), 17-271243 (Exp. 7/26/23), 17-271439 (Exp. 7/30/23), and 17-271562 (Exp. 8/1/23); and
• fentanyl, 5000 mcg/100 mL (50 mcg/mL), 100-mL bag (NDC 71286-2003-5), from lots 17-273074 (Exp. 8/28/23) and 17-273772 (Exp. 9/7/23).

Central Admixture Pharmacy Services voluntarily initiated the recalls July 17, 2023. On August 3, 2023, the FDA designated them Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used, or a remote possibility of serious harm.

Fentanyl is a Schedule II prescription opioid used to relieve moderate to severe pain.