Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56
Reported: January 31, 2024 Initiated: January 4, 2024 #D-0259-2024
Product Description
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56
Reason for Recall
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 38,496 bottles
- Distribution
- USA Nationwide
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 38,496 bottles.
Why was this product recalled? ▼
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 31, 2024. Severity: Moderate. Recall number: D-0259-2024.
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