RecallRadar

FDA Drug recall D-0336-2017

Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL

On 2017-01-11 the FDA classified a Class II recall of Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit 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-0336-2017
ClassificationClass II
Statusterminated
Initiated2016-09-21
Published2017-01-11
Last updated2026-09-13 11:51 UTC
CompanyWells Pharmacy Network
DistributionUS

Product

Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit 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: 04052016@16…All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. Known kit lot code: 04052016@16, 04072016@26, 04142016@65, 05172016@105, 06062016@137, 06152016@28, 06232016@61, 07272016@56, 08192016@108, 09062016@127 Known vial lot code: 03252016@6, 03312016@1, 04042016@30, 05052016@134, 05092016@57, 06072016@32, 06172016@120, 07222016@26, 07222016@26, 08122016@3, 08252016@3.

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-0336-2017%22

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