Drug Enforcement D-0259-2024

Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

Status

Terminated

Classification

Class II

Report Date

January 31, 2024

Termination Date

August 16, 2024

Product Information

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
Product quantity
38,496 bottles
Reason for recall
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Address
750 Corporate Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0259-2024
Event ID
93719
Recall initiation date
January 4, 2024
Center classification date
January 22, 2024
Code info
Lot #: 05220346, 05220369 Exp 1/31/ 2024; 05220582, Exp 2/29/2024; 05220861 Exp 3/31/2024
More code info
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