Agency classClass IIOur severity:Severe FDA (Drugs)·D-0214-2021·Announced 2021-01-13

SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling 6,710 fentanyl syringes distributed to hospitals nationwide due to a lack of assurance of sterility and potential defective caps.

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 for an injectable medication, which poses a significant risk of infection or serious injury.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling 6,710 units of fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe. The product is a Schedule II prescription-only medication manufactured by SCA Pharmaceuticals in Windsor, Connecticut.

The recall was initiated due to a lack of assurance of sterility and the potential for a defective syringe cap, which could result in a non-integral unit. The affected lots include #1220023109, #1220023255, #1220023256, #1220023257, #1220023334, and #1220023518, with expiration dates ranging from January 25, 2021, to February 8, 2021.

The product was distributed to hospitals nationwide. Healthcare facilities should check their inventory for these specific lot numbers and stop using the affected syringes. Patients who have received this medication should contact their healthcare provider for guidance.

The recalled product

Product: fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable Medication
Hazard: sterility
defective-cap
Affected units: 6,710

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 (10)

Lot #1220023109
BUD 1/25/2021
1220023255
BUD 1/26/2021
1220023256. BUD 1/26/2021
1220023257
BUD 1/28/2021
1220023334
BUD 2/2/2021 & 1220023518
BUD 2/8/2021.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 32 recalled by SCA Pharmaceuticals 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 32 products in this recall →

Same manufacturer · SCA Pharmaceuticals

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Same hazard · sterility