D-1055-2018 Class II Terminated
FDA drug recall D-1055-2018 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: 1 1-ml syringe.
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
- 1 1-ml syringe
Product Description
EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Reason for Recall
Lack of sterility assurance.
Distribution Pattern
Texas
Code Information
Lot: 58897:42 Use By: 07/04/2018