FDA-Drug2022-08-10Class III
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.
Glenmark Pharmaceuticals Inc., USA
Hazard
Defective Container: Tube split from side seam
Sold states
Nationwide in the USA
Affected count
654,756 tubes
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1304-2022Don't want to check this manually?
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