Why it was recalled
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
Product description
Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
Lot numbers, UPCs & expiration codes
Lot # 346191, Exp. 12/2016
Where it was sold
Nationwide 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-0295-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 21, 2015
- FDA report date
- Nov 25, 2015
- Quantity
- 13,896 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0295-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 72351
- Address
- 1925 W. Field Court, Suite 300
- Code information
- Lot # 346191, Exp. 12/2016
- Postal code
- 60045
- Report date
- Nov 25, 2015
- Product type
- Drugs
- Recall number
- D-0295-2016
- Classification
- Class III
- Recalling firm
- Akorn, Inc.
- Product quantity
- 13,896 bottles
- Termination date
- Nov 29, 2017
- Reason for recall
- Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Aug 21, 2015
- Initial firm notification
- Letter
- Center classification date
- Nov 16, 2015