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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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.
Related recalls
Same manufacturer · Akorn, Inc.
See all →- HighTobramycin Ophthalmic Solution Recalled Due to Incomplete Stability Studies
FDA (Drugs) · 2023-06-07
- HighGuaifenesin Oral Solution Recalled Due to Incomplete Stability Studies
FDA (Drugs) · 2023-06-07
- HighFDA Recalls Calcitriol Injection Due to Manufacturing Practice Violations
FDA (Drugs) · 2023-06-07
- HighAkorn Hydromorphone Hydrochloride Injection Recalled Due to CGMP Deviations
FDA (Drugs) · 2023-06-07
- HighMidazolam Injection Recalled Due to Manufacturing Compliance and Stability Study Issues
FDA (Drugs) · 2023-06-07
Same hazard · quality failure
See all →- HighIntervascular Recalls Cardioroot Woven Collagen Coated Vascular Grafts
FDA (Devices) · 2026-09-30
- ModerateSirolimus Tablets Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2021-09-29
- ModerateDr. Reddy's Atorvastatin Calcium Tablets Recalled for Failed Impurity Specifications
FDA (Drugs) · 2021-06-23
- SevereAuroMedics Recalls Acetaminophen Injection Due to Discoloration and pH Failures
FDA (Drugs) · 2021-02-10
- ModerateInvaGen Recalls Bupropion Hydrochloride Tablets for Dissolution Failures
FDA (Drugs) · 2018-04-11
Similar recalls
- ModerateAkorn Atropine Sulfate Eye Solution Recalled for Failed Stability Testing
FDA (Drugs) · 2023-02-15
- ModerateAkorn Atropine Sulfate Eye Drops Recalled Due to Manufacturing Compliance Failures
FDA (Drugs) · 2023-06-07
- SevereAkorn Recalls Gentamicin Sulfate Ophthalmic Solution Due to Impurities
FDA (Drugs) · 2019-03-20
- SevereAkorn Recalls Phenylephrine Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereAkorn Recalls Sulfacetamide Sodium Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2016-06-08
- ModerateAkorn Recalls Proparacaine Hydrochloride Ophthalmic Solution Due to Chemical Contamination
FDA (Drugs) · 2020-07-22