Recalls / Class II
Class IID-0947-2023
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.
- Affected lot / 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, 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. 8/20/2023; 36-249746, 36-249748, 36-249749, 36-249751, 36-249752, 36-249753, Exp. 8/21/2023; 36-250070, 36-250071, Exp. 8/22/2023; 36-250416, 36-250417, 36-250418, 36-250419, 36-250420, 36-250421, Exp. 8/23/2023; 36-251027, 36-251028, Exp. 8/24/2023; 36-251566, 36-251567, 36-251568, Exp. 8/28/2023; 36-251772, 36-251773, 36-251774, 36-251775, Exp. 8/29/2023; 36-252323, Exp. 8/31/2023
Why it was recalled
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2200 S 43rd Ave, N/A, Phoenix, Arizona 85043-3909
Distribution
- Quantity
- 77,554 Syringes.
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-07-14
- FDA classified
- 2023-08-01
- Posted by FDA
- 2023-08-09
- Terminated
- 2025-03-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0947-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.