Drug FDA Class III Completed Failed specifications
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
Taro Pharmaceuticals U.S.A., Inc. Published Aug 21, 2024
Risk level
Class IIIUnlikely to cause harm, but violates labeling or manufacturing rules.
Severity score 25/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Taro Pharmaceuticals U.S.A., Inc. or your place of purchase with questions, and see the source record below for full details.
Reason 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.
Hazards
Out-of-specification related impurities and degradation products · primarySubpotency
Affected products (1)
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
96 vials
Lot codes: AD12890
Code info: Lot # AD12890, Exp 09/30/2024
Affected areas
Product was distributed to one distributor
Timeline
- InitiatedAug 7, 2024
- PublishedAug 21, 2024
- Recall number
- D-0633-2024
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.