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Recall Observatory FDA recall evidence

Drug product

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Village: Kishanpura, Baddi Nalagarth Road, District: Solan, Himachal Pradesh-173205, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-298-17

D-1743-2019

August 07, 2019

Class III

Product summary

Firm
Glenmark Pharmaceuticals Inc., USA
Event
Event 83526
Status
Terminated
Classification
Class III
Quantity
31,224 tubes
Official record key
drug-enforcement:D-1743-2019

Official wording

Reason: Temperature Abuse: Complaints received of liquidy texture.

Code information: Lot #: 05180734, Exp. 03/2020

Distribution pattern: Nationwide with the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Temperature Abuse: Complaints received of liquidy texture.