D-1212-2019 Class II Terminated
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
- 6667 syringes
Product Description
Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, 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: EA241908 Exp. 4/24/2019; EB011905 Exp. 5/2/2019; EB081909 Exp. 5/9/2019; EB151910 Exp. 5/16/2019; EB251909 Exp. 5/26/2019; EC061907 Exp. 6/4/2019; EC151906 Exp. 6/13/2019