Rocuronium Br 100 mg/10mL recall: Sterility Concern
Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode…
Why was Rocuronium Br 100 mg/10mL recalled?
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 1220022998, BUD 1/21/2021; 1220023115, BUD 1/25/2021; 1220023163, BUD 1/26/2021; 1220023186, BUD 1/27/2021; 1220023234, BUD 1/31/2021; 1220023393, BUD 2/3/2021; 1220023477, BUD 2/4/2021; 1220023568, BUD 2/9/2021 & 1220023625, BUD 2/11/2021.
- Product
- Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode…
- Recalling firm
- SCA Pharmaceuticals
- Quantity
- 7,940 syringes
- Distribution
- Product was distributed to hospitals nationwide.
- Recall date
- January 13, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)