The Recall Desk
SevereFDA (Drugs)·D-0103-2020·Announced 2019-10-09

KRS Global Biotechnology Recalls Succinylcholine Chloride Syringes for Sterility Concerns

KRS Global Biotechnology is recalling 7,905 syringes of Succinylcholine Chloride (PF) due to a lack of assurance of sterility. The recall covers all lots remaining within expiry and is distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. 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 injectable drug, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

KRS Global Biotechnology, Inc. is recalling 7,905 syringes of SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, For IV Use-Injection. The product is identified by NDC 3321678418. The recall is being conducted because of a lack of assurance of sterility.

The recall covers all lots remaining within expiry. The product was distributed nationwide. The agency has classified this recall as Class II.

Consumers and healthcare providers should stop using the affected product and contact KRS Global Biotechnology, Inc. for further instructions or a refund.

The recalled product

Product
SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, For IV Use-Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678418
Affected units
7,905

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 →