Class II · Moderate risk
Difluprednate Ophthalmic Emulsion
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
National Drug Code
Is NDC 69097-0341-35 recalled?
Difluprednate · 1 BOTTLE in 1 CARTON (69097-341-35) / 5 mL in 1 BOTTLE
Yes — this exact package was recalled
3 FDA recalls name the code 69097-0341-35 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.
- Active ingredient
- Difluprednate
- Strength
- DIFLUPREDNATE .5 mg/mL
- Form
- Emulsion · Ophthalmic
- Labeler
- Cipla USA Inc.
- Type
- Human Prescription Drug
- Product code
- 69097-0341
Recalls naming this package
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion 0.05%
Lack of Assurance of Sterility: Complaints received of defective container closure.
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
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
- 69097-0410 Cinacalcet 3
- 69097-0411 Cinacalcet 3
- 69097-0412 Cinacalcet 3
- 69097-0142 Albuterol Sulfate 2
- 69097-0537 Testosterone Cypionate 2
- 69097-0870 Lanreotide Acetate 2
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