D-1176-2022 Class II Terminated
FDA drug recall D-1176-2022 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Jun 3, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery. The recall status is terminated (terminated May 25, 2023). Affected quantity: 27 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 13, 2022
- Initiation Date
- Jun 3, 2022
- Termination Date
- May 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 vials
Product Description
Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
Reason for Recall
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Distribution Pattern
nationwide.
Code Information
Lots JKX3267A & JKX3686A Exp. Date 08/2022 Lot JKX4700A, Exp Date 10/2022 Lot JKX5727A, Exp date 11/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1176-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026