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D-1454-2019 Class III Terminated

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

FDA drug recall D-1454-2019 was initiated by InvaGen Pharmaceuticals, Inc. on Jun 12, 2019 and is designated Class III. Reason for recall: Defective Container; actuator may improperly function and affect dose delivery. The recall status is terminated (terminated Jan 28, 2021). Affected quantity: 1776 bottles.

Recall Details

Product Type: Drugs
Report Date: Jul 10, 2019
Initiation Date: Jun 12, 2019
Termination Date: Jan 28, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1776 bottles

Product Description

Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: Cipla USA, Inc., Sunrise, FL 33323 NDC 69097-363-44

Reason for Recall

Defective Container; actuator may improperly function and affect dose delivery.

Distribution Pattern

Nationwide

Code Information

Lot GH80480 and GH80481, exp 3/2020

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1454-2019
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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