Drug recall D-1454-2019

Class III Terminated reported Jul 10, 2019

Product

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.

Lots and codes

Lot GH80480 and GH80481, exp 3/2020

Recall details

Recalling firm
InvaGen Pharmaceuticals, Inc., Central Islip, NY
Quantity
1776 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
June 12, 2019
Terminated
January 28, 2021

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