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Recall Observatory FDA recall evidence

Drug product

Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11

D-0087-2019

October 09, 2018

Class III

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 81213
Status
Terminated
Classification
Class III
Quantity
6,752 bottles
Official record key
drug-enforcement:D-0087-2019

Official wording

Reason: Defective Container: Repetitive complaints received indicating pump not working.

Code information: Lot #: K700085, K700087, Exp. November 2019

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container: Repetitive complaints received indicating pump not working.