CLASS II Drug recall · Reported 18 Sep 2013 · FDA Enforcement Report
Testosterone Hypoallergenic 200 MG/ML Injectable recalled
Beacon Hill Medical Pharmacy, P.C is recalling Testosterone Hypoallergenic 200 MG/ML Injectable and Testosterone Aqueous 100 MG/ML, distributed nationwide in the US. The recall was initiated on 26 Jul 2013 and the FDA has classified it as Class II.
Check your package
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-1002-2013
- FDA event ID
- 65876
- Recalling firm
- Beacon Hill Medical Pharmacy, P.C, Southfield, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jul 2013
- FDA classified
- 10 Sep 2013
- Reported
- 18 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Jul 2013 | Recall initiated by company | |
| 10 Sep 2013 | Classified by FDA | +46 days |
| 18 Sep 2013 | Published in enforcement report | +8 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; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Product as listed by the FDA
TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Where it was distributed
USA nationwide
Questions about this recall
Is Testosterone Hypoallergenic 200 MG/ML Injectable and Testosterone Aqueous 100 MG/ML recalled?
Yes. Beacon Hill Medical Pharmacy, P.C recalled Testosterone Hypoallergenic 200 MG/ML Injectable and Testosterone Aqueous 100 MG/ML on 26 Jul 2013. The recall is Class II and its status is Terminated. Recall number D-1002-2013.
Why was it recalled?
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Which lots are affected?
03112013@9, 05242013@17, 05312013@7, 06052013@21
Where was it sold?
USA nationwide
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Beacon Hill Medical Pharmacy, P.C
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|---|---|---|---|---|---|
| Drug | CLASS II | B-12 Rejuv 25 MG/ML Injectable, all configurations recalled | Beacon Hill Medical Pharmacy, P.C | Sterility | Nationwide |
| Drug | CLASS II | Sodium Bicarbonate PF 4% Injectable, all presentations recalled | Beacon Hill Medical Pharmacy, P.C | Sterility | Nationwide |
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| Drug | CLASS II | Edetate Disodium 150 MG/ML Injectable, all presentations recalled | Beacon Hill Medical Pharmacy, P.C | Sterility | Nationwide |
| Drug | CLASS II | Estradiol Cypionate 5, 10, 40 MG/ML Oil Inj Soln recalled | Beacon Hill Medical Pharmacy, P.C | Sterility | Nationwide |