Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Pharmathen International S.A. | Sapes, Greece | Makes it, tests it and packages it | Serious problems, FDA actionNov 21, 2025 · 2 inspections, 1 with FDA action |
Recalls
- Mar 13, 2026 · Class II · Cipla USA, Inc.
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Lots: Lot, expiry: 4401666IR1, Exp 8/31/2027; 4401703IR1, Exp 9/30/2027; 4401703IR2, EXP 9/30/2027; 4401704IR1, Exp 9/30/2027; 4401705IR1, Exp 9/30/2027; 4401706IR1, Exp 9/30/2027; 4401720IR1, Exp 9/30/2027; 4401721IR1, Exp 9/30/2027; 4401733IR1, Exp 9/30/2027; 4401770IR1, Exp 9/30/2027; 4401777IR1, Exp… - Jan 2, 2026 · Class II · Cipla USA, Inc.
Presence of Particulate Matter.
Lots: Lot, expiry: 4301954IR1 , exp 31/10/2026 ; 4301994IR1 , exp 31/10/2026 ; 4301995IR1 , exp 31/10/2026 ; 4301996IR1 , exp 31/10/2026 ; 4400005IR1 , exp 30/11/2026 ; 4400006IR1 , exp 30/11/2026 ; 4400007IR1 , exp 30/11/2026 ; 4400124IR1 , exp 30/11/2026 ; 4400154IR1 , exp 30/11/2026…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Lanreotide: every company that makes it
- Form
- injection, subcutaneous
- Strength
- 90 mg per 0.3 mL
- Approval
- NDA NDA215395
- On the market since
- Dec 24, 2021
- Package NDCs
69097-890-67- Official label
- DailyMed (National Library of Medicine), updated Sep 1, 2024
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