Agency classClass IIOur severity:Severe FDA (Drugs)·D-0211-2021·Announced 2021-01-13

SCA Pharmaceuticals Recalls Rocuronium Br Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling 13,096 syringes of Rocuronium Br 50 mg/5mL 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 the hazard involves a lack of assurance of sterility in a medical drug, which carries a significant risk of serious injury or death if contaminated.

Plain-English summary

SCA Pharmaceuticals is recalling 13,096 syringes of Rocuronium Br 50 mg/5mL (10 mg/mL) single-dose syringes. The recall involves two specific product configurations: 5 mL Single Dose Syringes with Red Labels (barcode 7000485009) and 5 mL Single Dose Syringes with White Labels (barcode 70004085028). The affected lots have expiration dates ranging from January 12, 2021, to February 11, 2021.

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. This defect poses a risk of contamination to the medication.

The product was distributed to hospitals nationwide. Healthcare facilities should check their inventory for the specific lot numbers and barcodes listed in the recall notice and stop using any affected syringes. Patients who have received this medication should contact their healthcare provider if they have concerns.

The recalled product

Product: Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little…
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable Medication
Hazard: sterility
contamination
Affected units: 13,096

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 (20)

a) Lot # 1220023011
BUD 1/12/2021
1220023027
BUD 1/19/2021
1220023151
BUD 1/26/2021
1220023152
1220023194
1220023228
BUD 1/28/2021
1220023358. BUD 2/3/2021
1220023396. BUD 2/3/2021
1220023398
BUD 2/10/2021
1220023569
BUD 2/9/2021 & 1220023633
BUD 2/11/2021. b)1220023031
1220023032
BUD 1/24/2021
1220023161

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 →

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Same hazard · sterility