D-1190-2022 Class II Terminated
FDA drug recall D-1190-2022 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Jun 21, 2022 and is designated Class II. Reason for recall: cGMP - Water leakage The recall status is terminated (terminated May 23, 2023). Affected quantity: 50860 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 20, 2022
- Initiation Date
- Jun 21, 2022
- Termination Date
- May 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50860 vials
Product Description
Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol- Baroda Highway, Halol-Baroda, Highway, Halol- 389 350, Gujarat, India, NDC 62756-015-40.
Reason for Recall
cGMP - Water leakage
Distribution Pattern
USA Nationwide
Code Information
HAC4337A
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1190-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026