Why it was recalled
Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Product description
Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059
Lot numbers, UPCs & expiration codes
Lot #: 20180507@21, Exp 7/1/2018; 20180511@9, 20180511@24, Exp 7/5/2018; 20180518@24, 20180518@31, 20180518@32, Exp 7/12/2018; 20180531@21, Exp 7/25/2018; 20180601@11, Exp 7/26/2018
Where it was sold
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-0918-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 29, 2018
- FDA report date
- Jul 18, 2018
- Quantity
- 3984 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0918-2018, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 80425
- Address
- 8821 Knoedl Ct
- Code information
- Lot #: 20180507@21, Exp 7/1/2018; 20180511@9, 20180511@24, Exp 7/5/2018; 20180518@24, 20180518@31, 20180518@32, Exp 7/12/2018; 20180531@21, Exp 7/25/2018; 20180601@11, Exp 7/26/2018
- Postal code
- 72205-4600
- Report date
- Jul 18, 2018
- Product type
- Drugs
- Recall number
- D-0918-2018
- Classification
- Class II
- Recalling firm
- SCA Pharmaceuticals
- Product quantity
- 3984 syringes
- Termination date
- May 1, 2019
- Reason for recall
- Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059
- Distribution pattern
- United States
- Recall initiation date
- Jun 29, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 12, 2018