Recalls / Class II
Class IID-1052-2018
Product
Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
- Affected lot / code info
- Lots: 58495:42 Use By: 05/22/2018; 58703/58733 Use By: 06/10/2018; 58852:42 Use By: 06/22/2018; 59006:42 Use By: 07/10/2018;
Why it was recalled
Lack of sterility assurance.
Recalling firm
- Firm
- Guardian Pharmacy Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7920 Elmbrook Dr Ste 108, N/A, Dallas, Texas 75247-4933
Distribution
- Quantity
- 4900 100-ml vials
- Distribution pattern
- Texas
Timeline
- Recall initiated
- 2018-05-17
- FDA classified
- 2018-08-08
- Posted by FDA
- 2018-08-15
- Terminated
- 2020-11-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1052-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.