Drug product
METHYLCOBALAMIN PRESERVATIVE FREE PREFILLED, Injectable Solution, 15 MG/ML, syringe size: 12 mL, 20 mL, 30 mL, 40 mL, 60 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
D-0108-2016
Product summary
- Event
- Event 71806
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 (12mL) syringe, 204 (20mL) syringe, 3 (30mL) syringes, 3 (40mL) syringes, 1 (60mL) syringe
- Official record key
drug-enforcement:D-0108-2016
Official wording
Reason: Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Code information: 01022015@27, 01212015@13, 02042015@2, 02182015@3, 03042015@3, 03092015@12, 03182015@19, 03252015@7, 04152015@3, 04292015@4, 05112015@2, 05132015@10, 05262015@1, 06032015@6, 06082015@6, 06152015@5, 06242015@3, 06292015@9, 07092014@1, 07292014@35, 08062014@3, 08272014@1, 09292014@12, 10202014@11, 11052014@5, 11262014@7, 12082014@11, 12292014@5, t04032015@17.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility