Recalls / Class II
Class IID-0125-2022
Product
METHYLCOBALAMIN 1MG/ML (1000MCG/ML) INJ 1MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected lot / code info
- Lot: 07292021:79 BUD: 10/27/2021; 09072021:33 BUD: 12/07/2021; 09072021:32 BUD: 12/07/2021; 08312021:30 BUD: 11/29/2021; 07222021:66 BUD: 10/20/2021; 08242021:10 BUD: 11/22/2021; 07262021:12 BUD: 10/24/2021; 08182021:08 BUD: 11/16/2021; 09072021:31 BUD: 12/07/2021; 09092021:32 BUD: 12/08/2021; 09212021:12 BUD: 12/20/2021; 09212021:88 BUD: 12/20/2021.
Why it was recalled
Lack of assurance of sterility
Recalling firm
- Firm
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 2950 Thousand Oaks Dr Ste 25, N/A, San Antonio, Texas 78247-3347
Distribution
- Quantity
- 324 vials
- Distribution pattern
- United States including Washington, D.C. and Puerto Rico
Timeline
- Recall initiated
- 2021-10-12
- FDA classified
- 2021-11-08
- Posted by FDA
- 2021-11-17
- Terminated
- 2023-10-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0125-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.