FDA Drug recall D-1201-2022
Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding
- FDA Drug
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding by Tmc Acquisition, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1201-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-07 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Tmc Acquisition |
| Distribution | US |
Product
Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Batch #: a) 01052210A1, Exp 4/5/2022; 10202101A1, Exp 4/18/2022; 01052210A1 7/4/2022; b)10202102A1, Exp 4/18/2022; 1202…Batch #: a) 01052210A1, Exp 4/5/2022; 10202101A1, Exp 4/18/2022; 01052210A1 7/4/2022; b)10202102A1, Exp 4/18/2022; 12022126A1, Exp 5/31/2022; 01052210A1, Exp 7/4/2022. |
|---|
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-1201-2022%22
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