Why it was recalled
Lack Of Assurance Of Sterility.
Product description
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40
Lot numbers, UPCs & expiration codes
Lot: 20170814@20 BUD: 11/12/2017
Where it was sold
Nationwide in the United States
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-0062-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 19, 2017
- FDA report date
- Nov 8, 2017
- Quantity
- 116 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0062-2018, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 78320
- Address
- 8821 Knoedl Ct
- Code information
- Lot: 20170814@20 BUD: 11/12/2017
- Postal code
- 72205-4600
- Report date
- Nov 8, 2017
- Product type
- Drugs
- Recall number
- D-0062-2018
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals, LLC
- Product quantity
- 116 bags
- Termination date
- May 1, 2019
- Reason for recall
- Lack Of Assurance Of Sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40
- Distribution pattern
- Nationwide in the United States
- Recall initiation date
- Oct 19, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 2, 2017