D-0977-2018 Class II Terminated
FDA drug recall D-0977-2018 was initiated by Sun Pharmaceutical Industries, Inc. on Jul 12, 2018 and is designated Class II. Reason for recall: Presence of Particulate Matter: organic and inorganic compounds detected in vials of product. The recall status is terminated (terminated Mar 11, 2019). Affected quantity: 5215 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 1, 2018
- Initiation Date
- Jul 12, 2018
- Termination Date
- Mar 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5215 units
Product Description
Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40
Reason for Recall
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: JKS0280A, Exp. 06/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0977-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026