Recalling firm
Taro Pharmaceuticals U.S.A., Inc.
Product type
Drug
Status
Completed
Report date
2024-08-21
Distribution
Product was distributed to one distributor
Firm state
NY
Product quantity
96 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Product description
Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01
Code / lot info
Lot # AD12890, Exp 09/30/2024
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.