Drug product
Methylcobalamin 1,000 mcg/mL, 10 mL and 30 mL. Compounded by Tri-Coast Pharmacy
D-0272-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,458 vials
- Official record key
drug-enforcement:D-0272-2017
Official wording
Reason: Lack of Assurance of Sterility
Code information: Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05312016KK, 05262016A (11/22/2016), 060920161 (12/06/2016), 07262016B (01/22/2017), 07062016C (12/31/2016), 08292016B (02/25/2017), 10132016F (04/11/2017), 10252016K (02/28/2017), 07262016C (01/22/2017), 09152016 (02/28/2017)
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility