Glenmark Pharmaceuticals Inc., USA recalls Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35,
Recalled August 10, 2022 · FDA recall D-1304-2022 · Glenmark Pharmaceuticals Inc., USA
Hazard
Defective Container: Tube split from side seam · FDA Class III
Units
654,756 tubes
Sold at
Nationwide in the USA
Description
Defective Container: Tube split from side seam
Product
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.
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →