D-0918-2018 Class II Terminated
FDA drug recall D-0918-2018 was initiated by SCA Pharmaceuticals on Jun 29, 2018 and is designated Class II. Reason for recall: Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding. The recall status is terminated (terminated May 1, 2019). Affected quantity: 3984 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 18, 2018
- Initiation Date
- Jun 29, 2018
- Termination Date
- May 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3984 syringes
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
Reason for Recall
Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Distribution Pattern
United States
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0918-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026