Why it was recalled
Lack of Assurance of Sterility; product has the potential to leak.
Product description
fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40
Lot numbers, UPCs & expiration codes
Lots: 20170509@17 BUD: 8/7/2017
Where it was sold
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-1034-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 14, 2017
- FDA report date
- Aug 2, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1034-2017, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 77770
- Address
- 8821 Knoedl Ct
- Code information
- Lots: 20170509@17 BUD: 8/7/2017
- Postal code
- 72205-4600
- Report date
- Aug 2, 2017
- Product type
- Drugs
- Recall number
- D-1034-2017
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals
- Termination date
- May 1, 2019
- Reason for recall
- Lack of Assurance of Sterility; product has the potential to leak.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 14, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 26, 2017