Why it was recalled
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product description
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 70004085012
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Product was distributed to hospitals nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0206-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 17, 2020
- FDA report date
- Jan 13, 2021
- Quantity
- 7,940 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0206-2021, exactly as published.
Show all FDA fields
- City
- Windsor
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 86990
- Address
- 755 Rainbow Rd Ste B
- Code information
- 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.
- Postal code
- 06095-1024
- Report date
- Jan 13, 2021
- Product type
- Drugs
- Recall number
- D-0206-2021
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 7,940 syringes
- Termination date
- Nov 2, 2021
- Reason for recall
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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 70004085012
- Distribution pattern
- Product was distributed to hospitals nationwide.
- Recall initiation date
- Dec 17, 2020
- Initial firm notification
- Letter
- Center classification date
- Jan 7, 2021