The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0051-2020·Announced 2019-10-09

FDA Recalls Fentanyl IV Bags Due to Sterility Concerns

KRS Global Biotechnology is recalling 1,882 bags of fentanyl citrate IV solution nationwide due to a lack of assurance of sterility.

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 FDA classified this recall as Class II, which corresponds to a 'Severe' severity score (4) under the rubric, as it involves a potential for temporary or medically reversible adverse health consequences.

Plain-English summary

KRS Global Biotechnology, Inc. is recalling 1,882 bags of fentanyl citrate in 0.9% sodium chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL fill in 150 mL IV bags. The product is prescription-only and is identified by NDC 33216286000. The recall is being conducted because of a lack of assurance of sterility.

The affected product was distributed nationwide. The recall includes all lots remaining within their expiration dates. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. Consumers should not use the product and should return it to the pharmacy or healthcare provider where it was obtained.

The recalled product

Product
fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 33216286000
Manufacturer
KRS Global Biotechnology, Inc
Category
Drug — IV Solution
Hazard
Affected units
1,882

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 →

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