The Recall Desk
HighFDA (Drugs)·D-1056-2023·Announced 2023-08-09

Succinylcholine Injectable Syringes Recalled for Sterility Validation Deficiency

Central Admixture Pharmacy Services Inc recalls 12,239 succinylcholine injection syringes (200 mg/10 mL) distributed nationwide due to lack of validation data for sanitization cycles.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical with sterility assurance deficiency and no reported illnesses or injuries. The hazard qualifies as a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.

Plain-English summary

Central Admixture Pharmacy Services Inc is recalling 12,239 syringes of succinylcholine 200 mg/10 mL (20 mg/mL concentration) distributed nationwide in the United States. Succinylcholine is an injectable medication administered during surgical anesthesia.

The recall was initiated because validation data for sanitization cycles are lacking, meaning the manufacturer cannot verify that their sterilization processes are adequate to ensure product sterility. This raises potential concerns about bacterial or fungal contamination in the affected lots.

The affected product includes multiple lot numbers (17-270532, 17-270538, 17-270601, 17-270888, 17-271680, 17-271828, 17-271959, 17-272232, 17-272239, 17-272338, 17-272452, 17-272463, 17-272551, 17-272557, 17-272800, 17-272819, 17-272889, 17-272917, 17-272978, 17-273077, 17-273166, 17-273604, 17-273729, 17-273731, 17-273854, and 17-273870) with expiration dates ranging from July 2023 through September 2023. All affected units were distributed nationwide.

Healthcare facilities and anesthesia practitioners who have received these syringes should immediately discontinue use of the affected lots and quarantine the product. Contact Central Admixture Pharmacy Services Inc regarding return or destruction. Report any adverse events to the FDA.

The recalled product

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
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Injectable Anesthesia
Hazard
  • sterility-failure
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot: 17-270532
  • 17-270538
  • Exp
  • 7/16/2023
  • 17-270601
  • 7/17/2023
  • 17-270888
  • 7/20/2023
  • 17-271680
  • 8/2/2023
  • 17-271828
  • 8/6/2023
  • 17-271959
  • 8/8/2023
  • 17-272232
  • 17-272239
  • 8/13/2023
  • 17-272338
  • 8/15/2023
  • 17-272452

Distribution

Distributed nationwide across the United States.

Related recalls

Same category