RecallRadar

FDA Drug recall D-0263-2017

HCG 11,000 IU Vial

On 2017-01-11 the FDA classified a Class II recall of HCG 11,000 IU Vial by Tri Coast Pharmacy, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0263-2017
ClassificationClass II
Statusongoing
Initiated2016-11-17
Published2017-01-11
Last updated2026-09-13 11:51 UTC
CompanyTri Coast Pharmacy
DistributionUS

Product

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

Reason

Lack of Assurance of Sterility

Identifiers

code_info
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 0615…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)

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0263-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.