Drug product
Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27
D-0427-2015
Product summary
- Event
- Event 70013
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 vials
- Official record key
drug-enforcement:D-0427-2015
Official wording
Reason: Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
Code information: Lot# 10082014@10
Distribution pattern: TX
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter