D-1153-2022 Class II Terminated
FDA drug recall D-1153-2022 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Jun 3, 2022 and is designated Class II. Reason for recall: CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for… The recall status is terminated (terminated May 24, 2023). Affected quantity: 97,450 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 29, 2022
- Initiation Date
- Jun 3, 2022
- Termination Date
- May 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 97,450 vials
Product Description
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
Reason for Recall
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
HAC1974A, HAC1978A, Exp 06/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1153-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026