Class III · Low risk
Atropine Sulfate Ophthalmic Solution
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
National Drug Code
Is NDC 17478-0215-02 recalled?
Atropine Sulfate Ophthalmic Solution
Yes — this exact package was recalled
1 FDA recall names the code 17478-0215-02 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
1 of these recalls is still ongoing.
This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.
Recalls naming this package
Class II · Moderate risk
Atropine Sulfate Ophthalmic Solution
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Atropine Sulfate Ophthalmic 1% Solution
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 17478-0283 See recall 3
- 17478-0622 See recall 3
- 17478-0711 See recall 3
- 17478-0030 See recall 2
- 17478-0062 See recall 2
- 17478-0070 See recall 2
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