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 Rock, AR 72205
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) Lot # 1220023011, BUD 1/12/2021; 1220023027, BUD 1/19/2021; 1220023151, BUD 1/26/2021; 1220023152, BUD 1/26/2021; 1220023194, BUD 1/26/2021; 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, BUD 1/19/2021; 1220023032, BUD 1/24/2021; 1220023161, BUD 1/26/2021 & 1220023224, BUD 1/28/2021.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- SCA Pharmaceuticals
- Reason for Recall:
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 Rock, AR 72205
Product Codes/Lot Numbers:
a) Lot # 1220023011, BUD 1/12/2021; 1220023027, BUD 1/19/2021; 1220023151, BUD 1/26/2021; 1220023152, BUD 1/26/2021; 1220023194, BUD 1/26/2021; 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, BUD 1/19/2021; 1220023032, BUD 1/24/2021; 1220023161, BUD 1/26/2021 & 1220023224, BUD 1/28/2021.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0211-2021
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