Recalls / Class II
Class IID-1071-2018
Product
Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
- Affected lot / code info
- Lots: 58409:42, Use By: 05/21/2018; 58899:42, Use By: 07/04/2018; 59215:42 Use By: 08/01/2018
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
- 2000 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-1071-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.