CLASS II Drug recall · Reported 19 Jun 2019 · FDA Enforcement Report
Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc recalled
Synthetopes is recalling Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc, distributed nationwide in the US. The recall was initiated on 28 May 2019 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-1399-2019
- FDA event ID
- 82969
- Recalling firm
- Synthetopes, Conway, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 May 2019
- FDA classified
- 20 Jun 2019
- Reported
- 19 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 28 May 2019 | Recall initiated by company | |
| 19 Jun 2019 | Published in enforcement report | +22 days |
| 20 Jun 2019 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Processing Controls.
Product as listed by the FDA
Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.
Where it was distributed
Nationwide.
Questions about this recall
Is Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc recalled?
Yes. Synthetopes recalled Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc on 28 May 2019. The recall is Class II and its status is Terminated. Recall number D-1399-2019.
Why was it recalled?
Lack of Processing Controls.
Which lots are affected?
All lots remaining within expiry.
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.
More recalls from Synthetopes
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sn-DMSA solution, Store Frozen, Not for Direct Injection recalled | Synthetopes | Other | Nationwide |
| Drug | CLASS II | Sn-Pyrophosphate Kit, 9 mg sodium pyrophosphate, Not recalled | Synthetopes | Temperature Abuse | Nationwide |
| Drug | CLASS II | Sulfur Colloid Reaction Vial, Thaw Before Use, Not recalled | Synthetopes | Temperature Abuse | Nationwide |
| Drug | CLASS II | Sn-Mertiatide Kit,1 milligram betiatide, Not recalled by Synthetopes | Synthetopes | Temperature Abuse | Nationwide |
| Drug | CLASS II | Sn-Tetrofosmin Kit, Thaw and Vent before use, Not recalled | Synthetopes | Temperature Abuse | Nationwide |