FDA Drug Class II — Moderate

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.

Hazard

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

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Products

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.
UPC
Lot #: 364667, Exp 12/20/2019

Units Affected

16,078 bottles

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