FDARecalled Jan 31, 2024 · #D-0259-2024
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, Distri...
Hazard
Class II — temporary health risk
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Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol Classification: Class II Distribution: USA Nationwide
Product details
- Product
- 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
- Type
- Drugs
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Model numbers
- 05220346
- UPCs
- —