Rocuronium Br 50 mg/5mL recall: Sterility Concern
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…
Why was Rocuronium Br 50 mg/5mL 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?
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.
- 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…
- Recalling firm
- SCA Pharmaceuticals
- Quantity
- 13,096 syringes
- Distribution
- Product was distributed to hospitals nationwide.
- Recall date
- January 13, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)