RecallRadar

FDA Drug recall D-1012-2016

TESTOSTERONE CYPIONATE 10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

On 2016-06-15 the FDA classified a Class II recall of TESTOSTERONE CYPIONATE 10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 by Well Care Compounding Pharmacy, citing lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1012-2016
ClassificationClass II
Statusterminated
Initiated2016-05-17
Published2016-06-15
Last updated2026-09-13 11:51 UTC
CompanyWell Care Compounding Pharmacy
DistributionNV

Product

TESTOSTERONE CYPIONATE 10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Reason

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Identifiers

code_info
Lot #: 02032016: 60@27, Exp. 05/03/2016; Lot #: 02222016: 29@62, Exp. 05/22/2016; Lot #: 03072016:87@66, Exp.06/06/20…Lot #: 02032016: 60@27, Exp. 05/03/2016; Lot #: 02222016: 29@62, Exp. 05/22/2016; Lot #: 03072016:87@66, Exp.06/06/2016; Lot #: 4152016:34@39, Exp. 07/18/2016; Lot #: 04282016:06@14, Exp. 07/27/2016.

Status history

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

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1012-2016%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.