D-1231-2019 Class II Terminated
FDA drug recall D-1231-2019 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: 390 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
- 390 bags
Product Description
Phenylephrine 20 mg NS 250 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: ED051911 Exp. 4/14/2019; ED081911 Exp. 4/17/2019; ED091910 Exp. 4/18/2019; ED101911 Exp. 4/19/2019; ED111909 Exp. 4/20/2019