The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0045-2020·Announced 2019-10-09

KRS Global Biotechnology Recalls L-Carnitine Vials Due to Sterility Concerns

KRS Global Biotechnology is recalling L-Carnitine vials because the company cannot ensure the product is sterile. The recall covers 6,447 vials distributed nationwide.

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 agency classification is FDA Class II. According to the rubric, an FDA Class II recall involving a risk-of-harm product (sterility failure in an injectable) without reported illness is scored as 4 (Severe) because it is a significant safety concern, though not a Class I critical risk.

Plain-English summary

KRS Global Biotechnology, Inc. is recalling L-Carnitine 27 mL Fill in a 30 mL Vials (NDC 3321676396). The recall is being conducted because the company lacks assurance of the sterility of the product. The affected product is a prescription-only medication intended for dilution use only.

The recall includes 6,447 vials of L-Carnitine 2,025 mg/27 mL (75 mg/mL). These products were distributed nationwide. The recall covers all lots remaining within their expiration dates.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396
Manufacturer
KRS Global Biotechnology, Inc
Category
Drug — Injectable
Hazard
Affected units
6,447

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 →

Same hazard · sterility failure

See all →

Similar recalls