D-1219-2019 Class II Terminated
FDA drug recall D-1219-2019 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: 3690 bags.
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
- 3690 bags
Product Description
Oxytocin 30 units in NS 500 mL bag, 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: EA241909 Exp. 4/24/2019; EA281909 Exp. 4/28/2019; EA301910 Exp. 4/30/2019; EB111909 Exp. 5/12/2019; EB141909 Exp. 5/15/2019; EB221908 Exp. 5/23/2019; EC061908 Exp. 6/4/2019; EC131909 Exp. 6/11/2019; EC261910 Exp. 6/24/2019