Why it was recalled
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Product description
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
Lot numbers, UPCs & expiration codes
Lot #: 364667, Exp 12/20/2019
Where it was sold
Nationwide in the USA and Puerto Rico
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-0839-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 16, 2019
- FDA report date
- Feb 19, 2020
- Quantity
- 16,078 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn Inc
Original FDA data
Every field from FDA enforcement report D-0839-2020, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 84913
- Address
- 1925 W Field Ct Ste 300
- Code information
- Lot #: 364667, Exp 12/20/2019
- Postal code
- 60045-4862
- Report date
- Feb 19, 2020
- Product type
- Drugs
- Recall number
- D-0839-2020
- Classification
- Class II
- Recalling firm
- Akorn Inc
- Product quantity
- 16,078 bottles
- Termination date
- Jul 29, 2022
- Reason for recall
- Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Dec 16, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 11, 2020