D-1225-2019 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
- a) 1357 bags; b) 6895 syringes
Product Description
CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 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: a) ED041904 Exp. 4/13/2019; ED051906 Exp. 4/14/2019; ED081905 Exp. 4/17/2019; ED091905 Exp. 4/18/2019; ED111905 Exp. 4/20/2019; b) EB271906 Exp. 4/13/2019; EB281906 Exp. 4/14/2019; EC051906 Exp. 4/19/2019; EC061905 Exp. 4/20/2019; EC071906 Exp. 4/21/2019; EC081907 Exp. 4/22/2019; EC111905 Exp. 4/25/2019; EC121907 Exp. 4/26/2019; EC131905 Exp. 4/27/2019; EC141905 Exp. 4/28/2019; EC151905 Exp. 4/29/2019; EC181906 Exp. 5/2/2019; EC191907 Exp. 5/3/2019; EC201905 Exp. 5/4/2019; EC211906 Exp. 5/5/2019; EC221907 Exp. 5/6/2019; EC251906 Exp. 5/9/2019; EC261906 Exp. 5/10/2019; EC271906 Exp. 5/11/2019; EC281906 Exp. 5/12/2019; EC011904 Exp. 5/16/2019; ED021908 Exp. 5/17/2019; ED031906 Exp. 05/18/2019; ED041905 Exp. 5/19/2019; ED051907 Exp. 5/20/2019; ED081906 Exp. 5/23/2019; ED091905 Exp. 5/24/2019; ED101906 Exp. 5/25/2019; ED111906 Exp. 5/26/2019