D-0837-2018 Class II Terminated
FDA drug recall D-0837-2018 was initiated by Lupin Pharmaceuticals Inc. on May 17, 2018 and is designated Class II. Reason for recall: Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release. The recall status is terminated (terminated May 1, 2019). Affected quantity: 43,922 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- May 30, 2018
- Initiation Date
- May 17, 2018
- Termination Date
- May 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43,922 cartons
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: M16317A1, M16317A4, M16317A5, Exp 11/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0837-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026