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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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