Testosterone Cypionate Injection
FDA Recall NDC 69097-536
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Testosterone Cypionate (NDC 69097-536). A significant event, classified as Class II, was initiated on Mar 22, 2019 by Cipla Usa Inc.. The reported reason for this action was: "Presence of Particulate Matter."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Particulate Matter.
Mar 22, 2019
Apr 24, 2019
75968 vials
Recall Profile & Regulatory Data
Event ID
82463
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
InvaGen Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.A.
Termination Date
Aug 16, 2022
Product Description
Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 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 69097-536-37.
Batch or Lot Expiration Information
Lot# Lots #: GH80216 Exp 1/2020; GH80322, GH80323 Exp 2/2020; GH90072 Exp 12/2020.
Affected Packages Involved in this Recall
69097-536-37Product
69097-537-37Product
69097-537-31Product
Class II Terminated
Presence of Particulate Matter.
Mar 22, 2019
Apr 24, 2019
12234 vials
Recall Profile & Regulatory Data
Event ID
82463
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
InvaGen Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.A.
Termination Date
Aug 16, 2022
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.
Batch or Lot Expiration 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.
Affected Packages Involved in this Recall
69097-536-37Product
69097-537-37Product
69097-537-31Product
Class II Terminated
Presence of Particulate Matter.
Mar 22, 2019
Apr 24, 2019
692538 vials
Recall Profile & Regulatory Data
Event ID
82463
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
InvaGen Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.A.
Termination Date
Aug 16, 2022
Product Description
Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single 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 69097-537-31.
Batch or Lot Expiration Information
Lot# :GH80009, GH80010, GH80011 Exp 12/2019; GH80568, GH80575, GH80579, GH80580, GH80581, GH80582 Exp 4/2020; GH80646, GH80664, GH80665, GH80684, GH80699, GH80700, GH80701, GH80746, GH80761, GH80765, GH80777 Exp 05/2020; GH80801, GH80823, GH80828, GH80878 Exp 06/2020; GH80967, GH80968, GH81033, GH81034 Exp 07/2020; GH81042, GH81154 Exp 08/2020; GH81255, GH81256, GH81288, GH81289, GH81310 Exp 10/2020 and GH81311 Exp 10/2020
Affected Packages Involved in this Recall
69097-536-37Product
69097-537-37Product
69097-537-31Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
