FDAClass IIIOctober 17, 2018

Altavera Levonorgestrel and Ethinyl Estradiol Tablets recall: Labeling Error

Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablets. Manufactured by…

Why was Altavera Levonorgestrel and Ethinyl Estradiol Tablets recalled?

Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.

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?

Lots: LF11838A Expiry May 2020; LF12107A, LF12106A, Expiry June 2020

Product
Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablets. Manufactured by…
Recalling firm
Xiromed LLC
Quantity
40064 3x28 units
Distribution
Nationwide in the USA
Recall date
October 17, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls