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.
Product description
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1
Lot numbers, UPCs & expiration codes
Lot# AC86809, AC86812, Exp Date: 01/31/2024
Where it was sold
Nationwide in the USA
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-0089-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 6, 2023
- FDA report date
- Nov 15, 2023
- Quantity
- 11,196 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0089-2024, exactly as published.
Show all FDA fields
- City
- Brampton
- Status
- Terminated
- Country
- Canada
- Event ID
- 93337
- Address
- 130 East Dr
- Code information
- Lot# AC86809, AC86812, Exp Date: 01/31/2024
- Report date
- Nov 15, 2023
- Product type
- Drugs
- Recall number
- D-0089-2024
- Classification
- Class III
- Recalling firm
- Taro Pharmaceuticals Inc.
- Product quantity
- 11,196 bottles
- Termination date
- Aug 27, 2024
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 6, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 6, 2023