NDC 62756-015
Testosterone Cypionate 200 mg per 1 mL injection, solution
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Halol, India | Makes it and tests it | Serious problems, FDA actionJun 13, 2025 · 12 inspections, 5 with FDA action |
Recalls
- Jun 21, 2022 · Class II · Sun Pharmaceutical Industries Inc
cGMP - Water leakage
Lots: HAC4337A - Jun 10, 2022 · Class II · Sun Pharmaceutical Industries Inc
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Lots: Lot: HAC3427A, EXP Date: 08/2023 - Jun 3, 2022 · Class II · Sun Pharmaceutical Industries Inc
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.
Lots: HAC1974A, HAC1978A, Exp 06/2023 - Jun 3, 2022 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Lots: Lots JKX3267A & JKX3686A Exp. Date 08/2022 Lot JKX4700A, Exp Date 10/2022 Lot JKX5727A, Exp date 11/2022 - Jan 11, 2021 · Class III · Sun Pharmaceutical Industries Inc
Incorrect Labeling: Incorrect lot number on secondary packaging
Lots: Lot JKX2553A - Jan 14, 2020 · Class II · Sun Pharmaceutical Industries, Inc.
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Lots: JKT0933A, JKT0935A, JKT1062A exp Mar-20; JKT1425A, JKT1483A exp Apr-20; JKT1575A, JKT1729A, JKT1730A, JKT1728A exp May-20 JKT2002A exp Jun-20; JKT3216A, JKT3217A exp Sep-20; JKT3589A, JKT3590A, JKT3626A exp Oct-20; JKT3864A, JKT3935A exp Dec-20 - Jan 14, 2020 · Class II · Sun Pharmaceutical Industries, Inc.
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Lots: a) JKT0075A, JKT0076A, JKT0213A, JKT0215A, JKT0369A, JKT0214A, JKT0368A, JKT0370A exp Jan-20; JKT0371A, JKT0515A, JKT0514A, JKT0516A, JKT0518A, JKT0517A, JKT0694A, JKT0695A, JKT0696A, exp Feb-20; JKT0697A, JKT0698A, JKT1063A, JKT1064A, JKT1065A, JKT1148A, JKT1068A, JKT1146A, JKT1066A exp Mar-20;… - Jul 12, 2018 · Class II · Sun Pharmaceutical Industries, Inc.
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Lots: Lot #: JKS0280A, Exp. 06/2019 - Mar 15, 2017 · Class II · Sun Pharmaceutical Industries, Inc.
Presence of Particulate Matter
Lots: JKR0744A, JKR0745A, JKR0750A, JKR0795A; Exp. 09/18
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Testosterone: every company that makes it
- Form
- injection, solution, intramuscular
- Strength
- 200 mg per 1 mL
- Approval
- ANDA ANDA201720
- On the market since
- Jun 17, 2013
- Package NDCs
62756-015-40- Official label
- DailyMed (National Library of Medicine), updated May 30, 2025
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