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.
Reported: August 10, 2022 Initiated: July 11, 2022 #D-1304-2022
Product Description
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.
Reason for Recall
Defective Container: Tube split from side seam
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 654,756 tubes
- Distribution
- Nationwide in the USA
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 654,756 tubes.
Why was this product recalled? ▼
Defective Container: Tube split from side seam
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 10, 2022. Severity: Low. Recall number: D-1304-2022.
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