FDA Drug recall D-0254-2016
HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkans…
- FDA Drug
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkans… 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-0254-2016 |
| 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
HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3083-99
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 Numbers: 20150806@22 BUD: 12/5/2015; 20150106@12 BUD: 11/28/2015; 20150106@20 BUD: 11/28/2015; 20150604@2 BUD: 10/…Lot Numbers: 20150806@22 BUD: 12/5/2015; 20150106@12 BUD: 11/28/2015; 20150106@20 BUD: 11/28/2015; 20150604@2 BUD: 10/3/2015; 20150604@2 BUD: 10/3/2015; 20150607@9 BUD: 1/2/2016; 20150806@22 BUD: 12/5/2015; 20151304@13 BUD: 10/10/2015; 20151506@22 BUD: 12/12/2015; 20152007@4 BUD: 1/16/2016; 20152206@20 BUD: 12/19/2015; 20152303@11 BUD: 9/19/2015; 20152303@2 BUD: 9/19/2015; 20152704@2 BUD: 10/24/2015; 20152707@3 BUD: 1/23/2016; 20152707@9 BUD: 1/23/2016; 20152303@11 BUD: 9/19/2015 |
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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-0254-2016%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.