PlainRecalls
FDA Drug Moderate Class II Terminated

Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3294-06

Reported: November 25, 2015 Initiated: September 12, 2015 #D-0259-2016

Product Description

Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3294-06

Reason for Recall

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.

Details

Recalling Firm
US Compounding Inc
Units Affected
103 vials
Distribution
Nationwide
Location
Conway, AR

Frequently Asked Questions

What product was recalled?
Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3294-06. Recalled by US Compounding Inc. Units affected: 103 vials.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 25, 2015. Severity: Moderate. Recall number: D-0259-2016.