Hydrocortisone and Acetic Acid Otic Solution recalled for failed specifications
Taro Pharmaceuticals recalls 11,196 bottles of Hydrocortisone and Acetic Acid Otic Solution nationwide due to failed quality specifications including out-of-spec impurities and lower-than-established assay levels discovered during stability testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. The recall is based on failed quality specifications (out-of-spec impurities and assay levels) discovered during stability testing, making this a precautionary quality-control recall rather than one involving actual reported harm.
Plain-English summary
Taro Pharmaceuticals Inc. is recalling 11,196 bottles of Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP (10ml dropper bottles) distributed nationwide in the United States. The affected product lot numbers are AC86809 and AC86812 with expiration date 01/31/2024. This is a prescription medication.
The recall was initiated due to failed quality specifications identified during stability testing. The testing revealed out-of-specification levels of Hydrocortisone-related impurities and Hydrocortisone assay levels that were slightly lower than the established specification. These quality deviations may affect product stability and performance.
Patients using this medication should consult their healthcare provider or pharmacist if they believe they have been affected. Those with affected lot numbers should stop using the product and contact their pharmacist regarding return or disposal. No illnesses or injuries related to this recall have been reported.
The recalled product
- Product
- HYDROCORTISONE AND ACETIC ACID (HYDROCORTISONE AND ACETIC ACID)
- Brand
- HYDROCORTISONE AND ACETIC ACID
- Manufacturer
- Taro Pharmaceuticals Inc.
- Category
- Drug — Otic Solution
- Hazard
- degradation
- impurity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot# AC86809
- AC86812
- Exp Date: 01/31/2024
Distribution
Distributed nationwide across the United States.
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