Agency classClass IIOur severity:Severe FDA (Drugs)·D-0191-2021·Announced 2021-01-13

SCA Pharmaceuticals Recalls Fentanyl and Ropivacaine Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine syringes 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall with potential for serious injury or hospitalization (implied by sterility failure in a drug product) corresponds to a severity score of 4 (Severe).

Plain-English summary

SCA Pharmaceuticals is recalling 1,774 single-dose syringes of fentanyl 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride. The recall is being conducted because of a lack of assurance of sterility and the potential for a defective syringe cap, which could result in a non-integral unit.

The affected product was distributed to hospitals nationwide. The recall includes specific lots with expiration dates ranging from February 15, 2021, to March 1, 2021. 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.

Healthcare facilities should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be quarantined and returned to SCA Pharmaceuticals or disposed of according to local regulations.

The recalled product

Product: fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable Medication
Hazard: sterility
defective-packaging
Affected units: 1,774

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 (8)

Lot # 1220023275
BUD 2/15/2021
1220023312
1220023433
2/22/2021
1220023515
BUD 2/24/2021 & 1220023671
BUD 3/1/2021.

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