Recalls / Class II
Class IID-0839-2020
Product
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.
- Affected lot / code info
- Lot #: 364667, Exp 12/20/2019
Why it was recalled
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Recalling firm
- Firm
- Akorn Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 16,078 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2019-12-16
- FDA classified
- 2020-02-11
- Posted by FDA
- 2020-02-19
- Terminated
- 2022-07-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0839-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.