RecallRadar

FDA Drug recall D-0947-2023

rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-601…

On 2023-08-09 the FDA classified a Class II recall of rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-601… by Central Admixture Pharmacy Services, citing lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0947-2023
ClassificationClass II
Statusterminated
Initiated2023-07-14
Published2023-08-09
Last updated2026-09-13 11:52 UTC
CompanyCentral Admixture Pharmacy Services
DistributionUS

Product

rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.

Reason

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Identifiers

code_info
Lot: 36-238805, 36-238806, 36-238808, 36-238809, 36-238810, 36-238811, Exp. 7/10/2023; 36-239229, 36-239319, 36-239320,…Lot: 36-238805, 36-238806, 36-238808, 36-238809, 36-238810, 36-238811, Exp. 7/10/2023; 36-239229, 36-239319, 36-239320, 36-239321, 36-239322, Exp. 7/11/2023; 36-239453, 36-239454, 36-239455, Exp. 7/12/2023; 36-239851, 36-239852, Exp. 7/13/2023; 36-240204, Exp. 7/16/2023; 36-240509, 36-240510, 36-240511, Exp. 7/17/2023; 36-241263, 36-241266, Exp. 7/19/2023; 36-241362, 36-241363, 36-241365, Exp. 7/20/2023; 36-241880, 36-241881, 36-241882, Exp. 7/23/2023; 36-242376, 36-242377, Exp. 7/24/2023; 36-242603, 36-242618, Exp. 7/25/2023; 36-242643, 36-242644, 36-242645, Exp. 7/26/2023; 36-243534, 36-243535, Exp. 7/30/2023; 36-243831, Exp. 7/31/2023; 36-244831, 36-244833, 36-244841, 36-244842, 36-244845, 36-244855, Exp. 8/01/2023; 36-245803, Exp. 8/02/2023; 36-246288, 36-246289, 36-246290, 36-246291, 36-246369, Exp. 8/03/2023; 36-246775, 36-246776, 36-246777, 36-246778, 36-246779, Exp. 8/07/2023; 36-248327, Exp. 8/13/2023; 36-249504, 36-249505, Exp. 8/18/2023; 36-249685, 36-249686, 36-249687, Exp.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0947-2023%22

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