Reported Aug 21, 2024 · Completed
Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton,…
Taro Pharmaceuticals U.S.A., Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Taro Pharmaceuticals U.S.A., Inc. · 3 Skyline Dr · Hawthorne, NY · 10532-2174
Is this the product you have?
- Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only
- Mfg byTaro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1
- Distributed byTaro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01
- Lot codes and dates
Lot # AD12890Exp 09/30/2024
- Amount recalled
- 96 vials
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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