Hi-Tech Pharmacal Recalls Subpotent Acetic Acid Otic Solution
Hi-Tech Pharmacal is recalling 11,472 bottles of Acetic Acid Otic Solution because the product failed potency testing. The recall covers nationwide distribution and Puerto Rico.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Hi-Tech Pharmacal Co., Inc. is recalling 11,472 bottles of Acetic Acid Otic Solution, USP, 15 mL, prescription only. The affected product is identified by Lot # 610593 and an expiration date of 06/13. The product was distributed nationwide and in Puerto Rico.
The recall was initiated because the product was found to be out-of-specification for the assay of acetic acid at the 18-month test station. This indicates the product is subpotent, meaning it may not contain the required amount of the active ingredient to be effective as intended.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal. The recall is classified as Class III by the FDA, indicating a low risk of adverse health consequences.
The recalled product
- Product
- Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.
- Manufacturer
- Hi-Tech Pharmacal Co., Inc.
- Category
- Drug — Otic Solution
- Hazard
- Affected units
- 11,472
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 #: 610593
- Exp 06/13
Distribution
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