Drug product
Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese Sulfate monohydrate USP 0.308 mg, Chromic Chloride hexahydrate USP 0.0205 mg), 10 mL Multi-Dose Vial, For IV Injection After Dilution, Dilute Before IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3201-07
D-0283-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,093 vials
- Official record key
drug-enforcement:D-0283-2016
Official wording
Reason: Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Code information: Lot Code: 20152804@35 BUD: 10/25/2015, 20150505@26 BUD: 11/1/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility