Recalls / Class II
Class IID-1067-2018
Product
Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
- Affected lot / code info
- Lot: 58758; 58760; 58756, 59095:42, 59093:42; 59091:42
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
- 60 20-ml syringes
- 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-1067-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.