D-0290-2017 Class II Ongoing

Recalled by Tri-Coast Pharmacy — Juno Beach, FL

FDA drug recall D-0290-2017 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: 7 vials.

Recall Details

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

Product Description

Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg). 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): 10192016A (04/17/2017).

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0290-2017
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.