CLASS II Drug recall · Reported 24 Feb 2016 · FDA Enforcement Report
testosterone cypionate, 100 mg/mL unit size recalled
Abbott's Compounding Pharmacy is recalling testosterone cypionate, 100 mg/mL unit size, This Rx is Compounded, Abbott's Compounding, distributed in California. The recall was initiated on 15 Jan 2016 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codes All lots
Quantity recalled 10 ml
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
Recall number D-0717-2016
FDA event ID 73090
Classification Class II
Status Terminated
Recall initiated 15 Jan 2016
FDA classified 17 Feb 2016
Reported 24 Feb 2016
Type Voluntary: Firm initiated
Customers notified by Press Release
Timeline
15 Jan 2016 Recall initiated by company 17 Feb 2016 Classified by FDA +33 days 24 Feb 2016 Published in enforcement report +7 days
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
testosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Questions about this recall
Why was it recalled? Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Which lots are affected? All lots
Where was it sold? CA
What should I do if I have it? Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean? Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event 42 other products · FDA event 73090 This product is part of a recall event; the main page for the event is progesterone/testosterone (ss oil) 0.25/20 mg/mL unit size recalled .
Reported Class Recall Company Reason Where 24 Feb 2016 CLASS II progesterone/testosterone (ss oil) 0.25/20 mg/mL unit size recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II hydroxyprogesterone w/ pres recalled by Abbott's Compounding Pharmacy Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine prostaglandin 30 mg/20 mcg/mL unit size recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II hydroxyprogesterone in sesame 250 mg/mL unit sizes recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phent, 25 mg/0.833 mg/mL unit size Refrigerate recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II Folic Acid, 5 mg/mL unit size, refrigerate recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II testosterone cypionate, 200 mg/mL and unit sizes recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II methylcobalamine 1 mg/mL and unit sizes, refrigerate recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine 30 mg/1mg/mL and unit size recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II methylcobalamine 4 mg/mL and unit sizes, refrigerate recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II Hydroxycobalamine 30 mg/mL unit size, refrigerate recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II methylcobalamine 10 mg/mL and unit sizes, refrigerate recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II Folic Acid, 10 mg/mL unit size, refrigerate recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II Bupivacaine, 0.25%, This Rx is Compounded recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II Insulin, 70/30 unit size, refrigerate recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine, 35 mg/2.5 mg/mL; unit size recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine prostaglandin 30 mg/30 mcg/mL unit size recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II papaverine phentolamine prostaglandin recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II Estradiol cypionate/Test cyprionate recalled Abbott's Compounding Pharmacy Sterility CA 24 Feb 2016 CLASS II calcium elemental, 3 mg/ unit: This Rx is Compounded recalled Abbott's Compounding Pharmacy Sterility CA
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