Recalls / Class II

Class IID-0263-2017

Product

HCG 11,000 IU Vial. Compounded by Tri-Coast Pharmacy

Affected lot / code info

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06152016A (12/12/2016), 07252016D (01/21/2017), 07112016C (01/07/2017), 08312016B (02/27/2017), 08262016B (02/22/2017), 08092016D (02/05/2017), 08052016A (02/01/2017), 09282016B (02/28/2017), 09222016D (02/28/2017), 09072016A (02/28/2017), 10252016J (02/28/2017), 10182016D (02/28/2017), 10102016H (02/28/2017), 11042016A (02/28/2017), 11012016E (02/28/2017)

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

Tri-Coast Pharmacy

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

14125 US Highway 1, N/A, Juno Beach, Florida 33408-1425

Distribution

Quantity

5,229 vials

Distribution pattern

Nationwide

Timeline

Recall initiated

2016-11-17

FDA classified

2017-01-04

Posted by FDA

2017-01-11

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0263-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.