Akorn Recalls Atropine Sulfate Ophthalmic Solution Due to Viscosity Failure
Akorn, Inc. is recalling 31,812 bottles of Atropine Sulfate Ophthalmic 1% Solution because testing revealed low viscosity results.
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 FDA classified this recall as 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
Akorn, Inc. is recalling 31,812 bottles of Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle. The product is sterile, prescription-only, and was distributed nationwide in the USA. The specific lot number is 011037A, and the NDC is 17478-215-05.
The recall was initiated because the product failed a stability specification during retain testing. Specifically, out-of-specification (OOS) low viscosity results were discovered. The FDA has classified this recall as Class III, which indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 31,812
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 (1)
- Lot: 011037A
Distribution
Distributed nationwide across the United States.
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