Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134
Reported: June 2, 2021 Initiated: March 15, 2021 #D-0534-2021
Product Description
Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134
Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Details
- Recalling Firm
- Cardinal Health Inc.
- Units Affected
- 348 droptainers
- Distribution
- FL, GA, SC
- Location
- Dublin, OH
Frequently Asked Questions
What product was recalled? ▼
Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134. Recalled by Cardinal Health Inc.. Units affected: 348 droptainers.
Why was this product recalled? ▼
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0534-2021.
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