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
Reported: August 21, 2024 Initiated: August 7, 2024 #D-0633-2024
Product Description
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
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.
Details
- Recalling Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Units Affected
- 96 vials
- Distribution
- Product was distributed to one distributor
- Location
- Hawthorne, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Taro Pharmaceuticals U.S.A., Inc.. Units affected: 96 vials.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 21, 2024. Severity: Low. Recall number: D-0633-2024.
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