CLASS II Drug recall · Reported 20 Feb 2019 · FDA Enforcement Report
Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection recalled
Promise Pharmacy is recalling Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, distributed nationwide in the US. The recall was initiated on 17 Dec 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-0452-2019
- FDA event ID
- 81810
- Recalling firm
- Promise Pharmacy, Palm Harbor, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2018
- FDA classified
- 8 Feb 2019
- Reported
- 20 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Dec 2018 | Recall initiated by company | |
| 8 Feb 2019 | Classified by FDA | +53 days |
| 20 Feb 2019 | Published in enforcement report | +12 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
Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it was distributed
Nationwide in the USA.
Questions about this recall
Is Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection recalled?
Yes. Promise Pharmacy recalled Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection on 17 Dec 2018. The recall is Class II and its status is Terminated. Recall number D-0452-2019.
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
Lots: 07052018@1 BUD: 1/1/2019; 09182018@6 BUD: 3/1/2019; 09212018@10 BUD: 3/4/2019; 10052018@1 BUD: 3/18/2019; 11062018@2 BUD: 4/19/2019
Where was it sold?
Nationwide in the USA.
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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|---|---|---|---|---|---|
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