Drug 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
D-0254-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,852 vials
- Official record key
drug-enforcement:D-0254-2016
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 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
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility