The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1011-2019·Announced 2019-03-27

Akorn Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Low Potency

Akorn Inc is recalling Hydrocortisone and Acetic Acid Otic Solution because routine stability testing revealed the drug was sub-potent.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is reasonably likely to cause temporary or medically reversible health consequences. The hazard is sub-potency, which is a lower risk than contamination or serious injury, fitting the Moderate category.

Plain-English summary

Akorn Inc is recalling Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle. The recall involves 15,322 bottles of the prescription medication, identified by Lot 357647 and an expiration date of 04/2019. The product was distributed nationwide in the United States and Puerto Rico.

The recall was initiated because routine stability testing at 12 months under controlled room temperature conditions showed out-of-specification results for the Hydrocortisone assay. This indicates the medication was sub-potent, meaning it contained less of the active ingredient than required.

Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

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
Manufacturer
Akorn Inc
Category
Drug — Ophthalmic/Ear Drops
Hazard

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: 357647
  • EXP 04/2019

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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