Recalls / Class II

Class IID-0300-2017

Product

Testosterone Cypionate in Sesame Oil, 200 mg/mL, (5 ML). 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): 05252016A (11/21/2016), 06272016B (12/24/2016), 07262016D (01/22/2017), 07182016H (01/14/2017), 07182016G (01/14/2017), 08252016C (02/21/2017), 08222016B (02/18/2017), 08102016A (02/06/2017), 09282016D (03/27/2017), 09222016E (03/21/2017), 09152016A (02/28/2017), 09062016B (02/28/2017), 10252016C (02/28/2017), 10042016E (04/02/2017).

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

7,168 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-0300-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.