Reported Nov 15, 2023 · Terminated
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals…
Taro Pharmaceuticals 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 Inc. · 130 East Dr · Brampton · N/A
Is this the product you have?
- Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd
- byTaro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist
- byTaro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1
- Lot codes and dates
Lot# AC86809AC86812
- Exp Date01/31/2024
- Amount recalled
- 11,196 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Taro Pharmaceuticals Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.