RecallRadar

FDA Drug recall D-1011-2016

TESTOSTERONE CYPIONATE 100MG/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 100MG/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-1011-2016
ClassificationClass II
Statusterminated
Initiated2016-05-17
Published2016-06-15
Last updated2026-09-13 11:51 UTC
CompanyWell Care Compounding Pharmacy
DistributionNV

Product

TESTOSTERONE CYPIONATE 100MG/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 #: 02042016: 80@58, Exp.05/04/2016; Lot #: 02222016:88@11, Exp.05/23/2016; Lot #: 03282016:42@5, Exp. 06/26/2016; L…Lot #: 02042016: 80@58, Exp.05/04/2016; Lot #: 02222016:88@11, Exp.05/23/2016; Lot #: 03282016:42@5, Exp. 06/26/2016; Lot #: 03292016:29@1, Exp.06/27/2016; Lot #: 03222016:22@19, Exp. 06/28/2016; Lot #: 04202016:46@30, Exp.07/19/2016.

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-1011-2016%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.