Drug product
METHYLCOBALAMIN, Injectable Solution, 15 MG/ML, syringe sizes: 5 mL; 6 mL; 10 mL; 15 mL; 20 mL; 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
D-0104-2016
Product summary
- Event
- Event 71806
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 (5mL) syringe, 1 (6mL) syringe, 18 (10mL), 1 (15mL) syringe, 3 (20mL) syringe, 3 (30mL) syringe
- Official record key
drug-enforcement:D-0104-2016
Official wording
Reason: Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Code information: t12312014@6, t12042014@26, t11252014@31, t10302014@35, t10282014@27, t10242014@14, t10032014@26, t10012014@18, t09302014@13, t09222014@22, t09172014@24, t09052014@1, t08132014@16, t07302014@2, t07222014@21, t06302015@5, t06182015@4, t04102015@10, t04062015@2, t03062015@8, t03032015@1, t02102015@22, t01272015@19, t01052015@31, 03312015@14
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility