D-1222-2019 Class II Terminated
FDA drug recall D-1222-2019 was initiated by CMC Enterprise Pharmacy on April 12, 2019 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated October 30, 2019). Affected quantity: 40 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2019
- Initiation Date
- April 12, 2019
- Termination Date
- October 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 syringes
Product Description
Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Reason for Recall
Lack of sterility assurance.
Distribution Pattern
NC
Code Information
Lots: ED051902 Exp. 4/14/2019; ED101902 Exp. 4/19/2019