D-0295-2016 Class III Terminated
FDA drug recall D-0295-2016 was initiated by Akorn, Inc. on Aug 21, 2015 and is designated Class III. 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… The recall status is terminated (terminated Nov 29, 2017). Affected quantity: 13,896 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 25, 2015
- Initiation Date
- Aug 21, 2015
- Termination Date
- Nov 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,896 bottles
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
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot # 346191, Exp. 12/2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0295-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026