D-0272-2017 Class II Ongoing

Recalled by Tri-Coast Pharmacy — Juno Beach, FL

FDA drug recall D-0272-2017 was initiated by Tri-Coast Pharmacy on Nov 17, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 1,458 vials.

Recall Details

Product Type
Drugs
Report Date
Jan 11, 2017
Initiation Date
Nov 17, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,458 vials

Product Description

Methylcobalamin 1,000 mcg/mL, 10 mL and 30 mL. Compounded by Tri-Coast Pharmacy

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide

Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05312016KK, 05262016A (11/22/2016), 060920161 (12/06/2016), 07262016B (01/22/2017), 07062016C (12/31/2016), 08292016B (02/25/2017), 10132016F (04/11/2017), 10252016K (02/28/2017), 07262016C (01/22/2017), 09152016 (02/28/2017)

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0272-2017
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.