The Recall Desk
SevereFDA (Drugs)·D-0839-2020·Announced 2020-02-19

Akorn Recalls Subpotent Hydrocortisone and Acetic Acid Otic Solution

Akorn Inc is recalling 16,078 bottles of Hydrocortisone and Acetic Acid Otic Solution due to low assay results for the hydrocortisone component.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe severity score (4) according to the rubric.

Plain-English summary

Akorn Inc is recalling 16,078 bottles of Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only. The product is manufactured by HI-TECH PHARMACAL CO., INC., located in Amityville, NY, and carries the NDC 50383-901-10.

The recall was initiated because the hydrocortisone portion of the product yielded low out-of-specification (OOS) assay results, indicating the medication is subpotent. The affected lot number is 364667, with an expiration date of 12/20/2019.

The product was distributed nationwide in the USA and Puerto Rico. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

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.
Manufacturer
Akorn Inc
Category
Drug — Ophthalmic/OTC
Hazard
Affected units
16,078

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 364667
  • Exp 12/20/2019

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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