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Recall Observatory FDA recall evidence

Drug product

succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2

D-1056-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
12,239 syringes
Official record key
drug-enforcement:D-1056-2023

Official wording

Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles

Code information: Lot: 17-270532, 17-270538, Exp, 7/16/2023; 17-270601, Exp, 7/17/2023; 17-270888, Exp, 7/20/2023; 17-271680, Exp, 8/2/2023; 17-271828, Exp, 8/6/2023; 17-271959, Exp, 8/8/2023; 17-272232, 17-272239, Exp, 8/13/2023; 17-272338, Exp, 8/15/2023; 17-272452, 17-272463, Exp, 8/16/2023; 17-272551, 17-272557, Exp, 8/17/2023; 17-272800, 17-272819, Exp, 8/22/2023; 17-272889, 17-272917, Exp, 8/23/2023; 17-272978, Exp, 8/24/2023; 17-273077, Exp, 8/28/2023; 17-273166, Exp, 8/29/2023; 17-273604, Exp, 9/5/2023; 17-273729, 17-273731, Exp, 9/6/2023; 17-273854, 17-273870, Exp, 9/10/2023;

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility