Taro Pharmaceuticals Inc. 2023-11-15 Health moderate FDA
Health · FDA · Recall #FDA-D-0089-2024
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only,… Recall
Issued November 15, 2023 · Taro Pharmaceuticals Inc.
In November 2023, Taro Pharmaceuticals Inc. recalled the Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only,…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Taro Pharmaceuticals Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Taro Pharmaceuticals Inc.
- Category
- Health
- Recall date
- November 15, 2023
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0089-2024
- Made in
- Canada
- Issuing agency
- FDA
In context
- Taro Pharmaceuticals Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.