Recalls / Class II

Class IID-0254-2016

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

Affected lot / 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: 10/3/2015; 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

Why it was recalled

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.

Recalling firm

Firm

US Compounding Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1270 Don's Lane, N/A, Conway, Arkansas 72032

Distribution

Quantity

7,852 vials

Distribution pattern

Nationwide

Timeline

Recall initiated

2015-09-12

FDA classified

2015-11-17

Posted by FDA

2015-11-25

Terminated

2017-03-30

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0254-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.