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.
Reported: May 30, 2018 Initiated: May 17, 2018 #D-0837-2018
Product Description
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.
Reason for Recall
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 43,922 cartons
- Distribution
- Nationwide in the USA
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 43,922 cartons.
Why was this product recalled? ▼
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 30, 2018. Severity: Moderate. Recall number: D-0837-2018.
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