FDA Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,350 syringes of Succinylcholine Chloride (PF) because the company cannot ensure the product is sterile.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an intravenous injection, which poses a significant risk of serious health consequences such as infection.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for 1,350 syringes of Succinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection. The product is manufactured by KRS Global Biotechnology, Inc. and is distributed nationwide.
The recall was initiated because the manufacturer lacks assurance of the product's sterility. The affected product is identified by NDC 3321678417. The recall covers all lots remaining within their expiration dates.
Healthcare providers and patients should stop using the affected syringes and contact their healthcare provider or the manufacturer for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678417
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable Medication
- Affected units
- 1,350
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)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 recalled by KRS Global Biotechnology, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 80 products in this recall →Related recalls
Same manufacturer · KRS Global Biotechnology, Inc
See all →- SevereKRS Global Biotechnology Recalls Lidocaine HCl Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereKRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereFDA Recalls Phenylephrine IV Bags Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- ModerateSermorelin and GHRP-2 Lyophilized Vials Recalled Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereKRS Global Biotechnology Recalls Phenylephrine IV Bags Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighSuccinylcholine Chloride Injection Recalled for Sterility Assurance Failure
FDA (Drugs) · 2024-04-03
- SevereFagron Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
FDA (Drugs) · 2017-07-12
- SevereSCA Pharmaceuticals Recalls Succinylcholine Syringes Due to Sterility Concerns
FDA (Drugs) · 2017-11-08
- SeverePremier Pharmacy Labs Recalls Succinylcholine Chloride Syringes for Sterility Concerns
FDA (Drugs) · 2019-07-03
- SevereSCA Pharmaceuticals Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
FDA (Drugs) · 2021-01-13
- HighSuccinylcholine chloride injection recalled for lack of sterility assurance
FDA (Drugs) · 2024-04-03