FDA Drug recall D-0134-2021
IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
- FDA Drug
- Class II
- ongoing
- Published 2020-12-23
On 2020-12-23 the FDA classified a Class II recall of IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN by Advanced Nutriceuticals, citing lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0134-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-11-30 |
| Published | 2020-12-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Advanced Nutriceuticals |
| Distribution | CA, CO, FL, IN, KY, OH, TX |
Product
IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Identifiers
| code_info | Lot # 1029202005,Exp 11/29/2020; Lot #1102202014, Exp 12/08/2020; Lot #1112202002, Exp 12/12/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0134-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.