Prescription drug
Where is Drospirenone and Ethinyl Estradiol and Levomefolic Acid made?
3 companies sell it under their own name. Their labels name 3 factories in Germany and India.
Germany 2India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Sandoz Inc. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium4 ingredients · NDC 0781-4075, 0781-4103 | Bayer AGMakes the active ingredient and tests it | Bergkamen, Germany | Problems found, fixed voluntarilyNov 2024 |
| Bayer Weimar GmbH und Co. KGMakes it and tests it | Weimar, Germany | Problems found, fixed voluntarilyNov 2022 | |
| Bayer HealthCare Pharmaceuticals Inc. Beyaz, Safyral4 ingredients · NDC 50419-407, 50419-403 | Bayer AGMakes the active ingredient and tests it | Bergkamen, Germany | Problems found, fixed voluntarilyNov 2024 |
| Lupin Pharmaceuticals, Inc.4 ingredients · NDC 68180-894, 68180-904 | Lupin LimitedMakes it, makes the active ingredient and packages it | Dhar, India | Problems found, fixed voluntarilySep 2024 |
Recalls
- Jun 23, 2023 · Class I · Lupin Pharmaceuticals Inc.
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test - Nov 19, 2021 · Class III · Lupin Pharmaceuticals Inc.
Subpotent Drug
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.