D-1123-2019 Class II Terminated
FDA drug recall D-1123-2019 was initiated by InvaGen Pharmaceuticals, Inc. on Mar 22, 2019 and is designated Class II. Reason for recall: Presence of Particulate Matter. The recall status is terminated (terminated Aug 16, 2022). Affected quantity: 12234 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 24, 2019
- Initiation Date
- Mar 22, 2019
- Termination Date
- Aug 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12234 vials
Product Description
Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 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 69097-537-37.
Reason for Recall
Presence of Particulate Matter.
Distribution Pattern
Nationwide in the U.S.A.
Code Information
Lot #: GH80159, GH80160, GH80161 Exp 01/2020; GH80489, GH80490, GH80502, GH80503, GH80504 Exp 03/2020; GH80557, GH80598, GH80601, GH80602 Exp 04/2020; GH80845, GH80846, GH80855, GH80856, GH80857, GH80877 Exp 06/2020; GH80903, GH80908, GH80931 Exp 07/2020; GH81047 Exp 08/2020.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1123-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026