FDA Drug recall D-0272-2016
Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conw…
- FDA Drug
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conw… by Us Compounding, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0272-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-12 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Us Compounding |
| Distribution | US |
Product
Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3137-02
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.
Identifiers
| code_info | Lot Code: 20150604@4 BUD: 10/3/2015, 20152205@1 BUD: 11/18/2015, 20152303@3 BUD: 9/19/2015, 20150604@1 BUD: 10/3/2015,…Lot Code: 20150604@4 BUD: 10/3/2015, 20152205@1 BUD: 11/18/2015, 20152303@3 BUD: 9/19/2015, 20150604@1 BUD: 10/3/2015, 20151304@27 BUD: 9/19/2015, 20151506@19 BUD: 12/12/2015, 20151506@27R BUD: 11/28/2015, 20151603@2 BUD: 9/12/2015, 20152004@13 BUD: 10/17/2015, 20152206@13 BUD: 12/19/2015, 20152906@7 BUD: 12/26/2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0272-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.