CLASS II Drug recall · Reported 6 Apr 2022 · FDA Enforcement Report
(ca) Gonadorelin 2 MG/ML Injectable recalled by Drug Depot, Inc
Drug Depot, Inc is recalling (ca) Gonadorelin 2 MG/ML Injectable, distributed nationwide in the US. The recall was initiated on 23 Mar 2022 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-0729-2022
- FDA event ID
- 89808
- Recalling firm
- Drug Depot, Inc, Palm Harbor, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Mar 2022
- FDA classified
- 29 Mar 2022
- Reported
- 6 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Mar 2022 | Recall initiated by company | |
| 29 Mar 2022 | Classified by FDA | +6 days |
| 6 Apr 2022 | 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 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
(CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy
Where it was distributed
Nationwide in the USA including Puerto Rico.
Questions about this recall
Is (ca) Gonadorelin 2 MG/ML Injectable recalled?
Yes. Drug Depot, Inc recalled (ca) Gonadorelin 2 MG/ML Injectable on 23 Mar 2022. The recall is Class II and its status is Terminated. Recall number D-0729-2022.
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
Lots: 749842 BUD: 7/13/2022; 749568 BUD: 7/12/2022; 752053 BUD: 7/23/2022; 752817 BUD: 7/25/2022; 757404 BUD: 8/21/2022; 757915 BUD: 8/23/2022; 757321 BUD: 8/20/2022; 753718 BUD: 7/30/2022
Where was it sold?
Nationwide in the USA including Puerto Rico.
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.
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|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone Cypionate/Anastrozole *GS* Oil 200MG/1MG/ML Injectable recalled | Drug Depot, Inc | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate *GS* Oil 200 MG/ML Injectable recalled | Drug Depot, Inc | Sterility | Nationwide |
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| Drug | CLASS II | Testosterone Cypionate/Propionate *Ses* Oil 160MG/20MG/ML Injectable recalled | Drug Depot, Inc | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate/ Dhea *GS* 200/10MG/ML Injectable recalled | Drug Depot, Inc | Sterility | Nationwide |