Levonorgestrel and Ethinyl Estradiol Tablets recall: Labeling Error
Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India…
Why was Levonorgestrel and Ethinyl Estradiol Tablets recalled?
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 8508F004A; Exp. 02/20
- Product
- Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India…
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 5,790 cartons (526,890 tablets)
- Distribution
- Product was distributed throughout the United States.
- Recall date
- October 24, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)