Recalls / Class II
Class IID-1011-2019
Product
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
- Affected lot / code info
- Lot: 357647, EXP 04/2019
Why it was recalled
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Recalling firm
- Firm
- Akorn Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 15,322 10 ml bottles
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2019-03-12
- FDA classified
- 2019-03-20
- Posted by FDA
- 2019-03-27
- Terminated
- 2022-08-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1011-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.