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D-1125-2019 Class II Terminated

Recalled by InvaGen Pharmaceuticals, Inc. — Central Islip, NY

FDA drug recall D-1125-2019 was initiated by InvaGen Pharmaceuticals, Inc. on Mar 22, 2019 and is designated Class II. Reason for recall: Presence of Particulate Matter. The recall status is terminated (terminated Aug 16, 2022). Affected quantity: 75968 vials.

Recall Details

Product Type: Drugs
Report Date: Apr 24, 2019
Initiation Date: Mar 22, 2019
Termination Date: Aug 16, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 75968 vials

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.

Reason for Recall

Presence of Particulate Matter.

Distribution Pattern

Nationwide in the U.S.A.

Code Information

Lots #: GH80216 Exp 1/2020; GH80322, GH80323 Exp 2/2020; GH90072 Exp 12/2020.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1125-2019
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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