Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Reported: August 14, 2019 Initiated: July 23, 2019 #D-1586-2019
Product Description
Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Reason for Recall
GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- N/A
- Distribution
- Nationwide within the United States
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: N/A.
Why was this product recalled? ▼
GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 14, 2019. Severity: Moderate. Recall number: D-1586-2019.
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