My Way recall
My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.
Why was My Way recalled?
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
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 #: M16317A1, M16317A4, M16317A5, Exp 11/18
- Product
- My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 43,922 cartons
- Distribution
- Nationwide in the USA
- Recall date
- May 30, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)