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.

FDA recall notice · announced February 19, 2020 · Akorn

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot #: 364667, Exp 12/20/2019
Quantity: 16,078 bottles
Status: Terminated
Products in this recall event:
- 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. (D-0839-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.