CLASS II Drug recall · Reported 5 Sep 2018 · FDA Enforcement Report
Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd recalled
Pharmcore is recalling Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd, distributed nationwide in the US. The recall was initiated on 2 Aug 2018 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-1153-2018
- FDA event ID
- 80699
- Recalling firm
- Pharmcore, Hallandale Beach, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Aug 2018
- FDA classified
- 28 Aug 2018
- Reported
- 5 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Aug 2018 | Recall initiated by company | |
| 28 Aug 2018 | Classified by FDA | +26 days |
| 5 Sep 2018 | 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.
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
Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of assurance of sterility.
Which lots are affected?
Lot: IPA3-17 Exp. 07/2018
Where was it sold?
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.
Other products in this recall event
8 other products · FDA event 80699| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Human Chorionic Gonadotropin 6000 IU Vial Lyophilized recalled | Pharmcore | Sterility | Nationwide | |
| CLASS II | Human Chorionic Gonadotropin 20000 IU Vial Lyophilized recalled | Pharmcore | Sterility | Nationwide | |
| CLASS II | Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale recalled | Pharmcore | Sterility | Nationwide | |
| CLASS II | Human Chorionic Gonadotropin 5000 IU Vial Lyophilized recalled | Pharmcore | Sterility | Nationwide | |
| CLASS II | Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd recalled | Pharmcore | Sterility | Nationwide | |
| CLASS II | Human Chorionic Gonadotropin 4000 IU Vial Lyophilized recalled | Pharmcore | Sterility | Nationwide | |
| CLASS II | Human Chorionic Gonadotropin 2500 IU Vial Lyophilized recalled | Pharmcore | Sterility | Nationwide | |
| CLASS II | Human Chorionic Gonadotropin 11000 IU Vial Lyophilized recalled | Pharmcore | Sterility | Nationwide |
More recalls from Pharmcore
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Human Chorionic Gonadotropin 11000 IU Vial Lyophilized recalled | Pharmcore | Sterility | Nationwide |
| Drug | CLASS II | Human Chorionic Gonadotropin 2500 IU Vial Lyophilized recalled | Pharmcore | Sterility | Nationwide |
| Drug | CLASS II | Human Chorionic Gonadotropin 4000 IU Vial Lyophilized recalled | Pharmcore | Sterility | Nationwide |
| Drug | CLASS II | Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd recalled | Pharmcore | Sterility | Nationwide |
| Drug | CLASS II | Human Chorionic Gonadotropin 5000 IU Vial Lyophilized recalled | Pharmcore | Sterility | Nationwide |