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IV Bags Recalled
A lack of assurance of sterility has prompted Central Admixture Pharmacy Services Inc to recall numerous lots of intravenous epinephrine products. According to the August 9, 2023, US Food and Drug Administration (FDA) Enforcement Report, “validation data for decontamination cycles is lacking.”
The recall affects the following products, which were distributed throughout the United States:
- epinephrine 2 mg/250 mL added to dextrose 5%, 8 mcg/mL, IV bag (NDC 72196-6030-1), from lot 36-251702 (Exp 8/29/23);
- epinephrine 4 mg/250 mL added to dextrose 5%, IV bag (NDC 72196-7018-1), from lots 36-239245 (Exp 7/10/23); 36-241047 (Exp 7/18/23); 36-241440, 36-241441, and 36-241442 (Exp 7/20/23); 36-242432 (Exp 7/25/23); 36-243662 (Exp 7/30/23); 36-246152, 36-246153, and 36-246158 (Exp 8/3/23); 36-246730, 36-246731, and 36-246732 (Exp 8/6/23); 36-247332, 36-247334, and 36-247337 (Exp 8/8/23); 36-249469 (Exp 8/17/23); 36-249589 (Exp 8/18/23); 36-250300 (Exp 8/23/23); 36-251335 (Exp 8/27/23); and 36-254370 (Exp 9/4/23);
- epinephrine 8 mg/250 mL added to dextrose 5%, 32 mcg/mL, IV bag (NDC 72196-7019-1), from lots 36-240224 (Exp 7/16/23); 36-242322 (Exp 7/24/23); 36-242445 (Exp 7/25/23); 36-243305 (Exp 7/27/23); 36-243813 (Exp 7/31/23); 36-246166 and 36-246167 (Exp 8/3/23); 36-247670 (Exp 8/9/23); 36-248992 (Exp 8/16/23); 36-249468 (Exp 8/17/23); 36-249590 (Exp 8/18/23); 36-251336 and 36-251644 (Exp 8/27/23); 36-251461 (Exp 8/28/23); 36-255531 (Exp 9/7/23); and 36-255532 (Exp 9/7/23); and
- epinephrine 4 mg/250 mL added to 0.9% sodium chloride, IV bag (NDC 72196-8093-1), from lots 36-239250 (Exp 7/10/23); 36-240225 (Exp 7/16/23); 36-241268 and 36-241270 (Exp 7/19/23); 36-241443 (Exp 7/20/23); 36-242436 and 36-242439 (Exp 7/25/23); 36-241443 (Exp 7/20/23); 36-242436 and 36-242439 (Exp 7/25/23); 36-243517 and 36-243738 (Exp 7/30/23); 36-245656 (Exp 8/2/23); 36-246154, 36-246169, 36-246672, 36-246673, and 36-246674 (Exp 8/3/23); 36-247015, 36-247016, and 36-247017 (Exp 8/7/23); 36-247339, 36-247341, 36-247342, and 36-247343 (Exp 8/8/23); 36-249466 and 36-249467 (Exp 8/17/23); 36-249591 and 36-249592 (Exp 8/18/23); 36-251338 (Exp 8/27/23); 36-251940 (Exp 8/30/23); and 36-254371, 36-254372, 36-254373, and 36-254375 (Exp 9/4/23).
Central Admixture Pharmacy Services voluntarily initiated the recall July 14, 2023. The FDA designated it Class II on August 1, 2023. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Epinephrine is a prescription alpha- and beta-adrenergic agonist used in the treatment of life-threatening allergic reactions or low blood pressure associated with septic shock.
