Drug product
METHYLCOBALAMIN MDV, Injectable Solution, 1 MG/ML, syringe sizes: 4 mL; 10 mL; 12 mL; 15mL; 30 mL; 50 mL; and 60 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
D-0105-2016
Product summary
- Event
- Event 71806
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 (4mL) syringe, 5 (10mL) syringes, 1 (12mL) syringe, 4 (15mL) syringes, 13 (30mL) syringes, 2 (50mL) syringes, 3 (60mL) syringes
- Official record key
drug-enforcement:D-0105-2016
Official wording
Reason: Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Code information: t12232014@10, t12052014@10, t11182014@16, t11182014@1, t10202014@5, t10132014@2, t09292014@7, t07082015@6, t07082015@30, t06112015@31, t06092015@34, t06052015@27, t06022015@9, t05282015@22, t05262015@8, t05202015@31, t04272015@11, t04132015@19, t03182015@46, t03172015@15, t03052015@22, t01192015@5. t06242015@31, t04022015@16, t02182015@34, t04172015@25, t05132015@30, t06192015@17
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility