The Recall Desk
HighFDA (Drugs)·D-0307-2022·Announced 2022-01-05

SterRx Succinylcholine Chloride Injection Recalled for Sterility Assurance

SterRx is recalling Succinylcholine Chloride Injection 20 mg/mL vials (1,000 mL) distributed nationwide due to lack of assurance of sterility. The 3,540 affected bags may pose a risk to patients receiving this injectable drug.

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 a Class II FDA drug recall involving a sterility defect in an injectable product. Although the source text does not explicitly state reported illnesses or injuries, sterility assurance failures in injectable drugs present a high risk of infection—a serious harm. The rubric establishes that high-risk hazards without yet-reported injury are scored at 3 (High).

Plain-English summary

SterRx, LLC is recalling Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL vials (NDC 70324-826-01) due to lack of assurance of sterility. The affected product was distributed nationwide in the United States.

This is a Class II recall. The manufacturer identified a deficiency in sterility assurance for the affected batches, identified by lot codes S21367/CBA (18-Nov-21) and S21403/CCL (9-Dec-21). A total of 3,540 bags are affected by this recall.

Succinylcholine Chloride is a prescription injectable medication used as a muscle relaxant during anesthesia. If the product lacks sterility assurance, patients receiving injections from affected vials may be at risk of infection.

Healthcare providers and patients should stop using affected vials immediately and contact their pharmacy or healthcare provider. Patients who have received injections from recalled vials should consult their healthcare provider if they have concerns about potential infection.

The recalled product

Product
Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-826-01.
Manufacturer
SterRx, LLC
Category
Drug — Injectable / Anesthetic
Hazard
  • sterility-assurance
  • infection-risk
  • contamination

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 (1)

  • S21367/CBA 18-Nov-21 S21403/CCL 9-Dec-21

Distribution

Distributed nationwide across the United States.

Related recalls

Same category