FDAClass IIJanuary 11, 2017

Testosterone Cypionate in Grapeseed Oil Injectable recall: Sterility Concern

Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

Why was Testosterone Cypionate in Grapeseed Oil Injectable recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot codes: 03282016@16, 03302016@4, 04042016@10, 04262016@3, 05162016@2, 06032016@2, 07062016@10, 08262016@2 b) Known lot code: 04012016@4, 04182016@6, 04282016@7, 05022016@4, 06142016@19, 08102016@22. c) Known lot code: 04042016@7, 05022016@9, 05272016@2, 06272016@13, 07292016@8, 08192016@10 d) Known lot code: 03242016@12, 04082016@6, 04142016@2, 04192016@5, 04272016@4, 05092016@4, 05232016@17, 06122016@6, 06082016@2, 06142016@148, 06162016@9, 06172016@13, 06232016@78, 06282016@31, 07122016@20, 08012016@25, 08032016@12, 08042016@13.

Product
Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Recalling firm
Wells Pharmacy Network LLC
Quantity
a) 694 vials b) 389 vials c) 695 vials d) 5193 vials
Distribution
Nationwide
Recall date
January 11, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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