SCA Pharmaceuticals Recalls Rocuronium Br Syringes Due to Sterility Concerns

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.

Distribution

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