Why it was 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.
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
Lot numbers, UPCs & expiration codes
Lot # AD12890, Exp 09/30/2024
Where it was sold
Product was distributed to one distributor
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0633-2024
- Classification
- Class III
- Status
- Completed
- Recall initiated
- Aug 7, 2024
- FDA report date
- Aug 21, 2024
- Quantity
- 96 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0633-2024, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Completed
- Country
- United States
- Event ID
- 95125
- Address
- 3 Skyline Dr
- Code information
- Lot # AD12890, Exp 09/30/2024
- Postal code
- 10532-2174
- Report date
- Aug 21, 2024
- Product type
- Drugs
- Recall number
- D-0633-2024
- Classification
- Class III
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 96 vials
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to one distributor
- Recall initiation date
- Aug 7, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2024