FDA Drug recall D-1125-2019
Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactu…
- FDA Drug
- Class II
- terminated
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class II recall of Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactu… by Invagen Pharmaceuticals, citing presence of Particulate Matter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1125-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-22 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Invagen Pharmaceuticals |
| Distribution | US |
Product
Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-536-37.
Reason
Presence of Particulate Matter.
Identifiers
| ndc | 69097-536-37 |
|---|---|
| ndc | 69097-537-37 |
| ndc | 69097-537-31 |
| code_info | Lots #: GH80216 Exp 1/2020; GH80322, GH80323 Exp 2/2020; GH90072 Exp 12/2020. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1125-2019%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.