D-1073-2018 Class II Terminated
FDA drug recall D-1073-2018 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: 40 10-ml vials.
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
- 40 10-ml vials
Product Description
Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. 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: 58913:42 Use By: 06/05/2018