D-1011-2019 Class II Terminated
FDA drug recall D-1011-2019 was initiated by Akorn Inc on March 12, 2019 and is designated Class II. Reason for recall: Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature. The recall status is terminated (terminated August 1, 2022). Affected quantity: 15,322 10 ml bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 27, 2019
- Initiation Date
- March 12, 2019
- Termination Date
- August 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,322 10 ml bottles
Product Description
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10
Reason for Recall
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Lot: 357647, EXP 04/2019