US Drug Recall Register
Class III · Low risk Terminated Initiated Jun 12, 2019 (7 years ago)

Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

What was recalled

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

Recalling firm
InvaGen Pharmaceuticals, Inc.
NDC code
69097-363-44
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1454-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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