D-1053-2018 Class II Terminated
FDA drug recall D-1053-2018 was initiated by Guardian Pharmacy Services on May 17, 2018 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated November 25, 2020). Affected quantity: 5000 500-ml bags.
Recall Details
- Product Type
- Drugs
- Report Date
- August 15, 2018
- Initiation Date
- May 17, 2018
- Termination Date
- November 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5000 500-ml bags
Product Description
Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Reason for Recall
Lack of sterility assurance.
Distribution Pattern
Texas
Code Information
Lots: 58555:42, 58567:42, 58563:42, 58547:42, 58565:42, Use By: 05/25/2018