RecallRadar

FDA Drug recall D-0393-2017

Sermorelin Acetate/GHRP (2)/Theanine 15 mg/5.4 mg/75 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

On 2017-01-11 the FDA classified a Class II recall of Sermorelin Acetate/GHRP (2)/Theanine 15 mg/5.4 mg/75 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL by Wells Pharmacy Network, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0393-2017
ClassificationClass II
Statusterminated
Initiated2016-09-21
Published2017-01-11
Last updated2026-09-13 11:51 UTC
CompanyWells Pharmacy Network
DistributionUS

Product

Sermorelin Acetate/GHRP (2)/Theanine 15 mg/5.4 mg/75 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

Reason

Lack of Assurance of Sterility

Identifiers

code_info
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05162016@37…All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 05162016@37, 06172016@161, 06242016@135, 08112016@121. Known vial lot code: 04202016@8, 05252016@33, 05312016@47, 08042016@39.

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-0393-2017%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.