NDC 70710-1048
Erythromycin 500 mg tablet, film coated
On the label: Zydus Pharmaceuticals (USA) Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
Recalls
- Apr 29, 2026 · Class II · Zydus Pharmaceuticals (USA) Inc
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Lots: Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026. - Apr 29, 2026 · Class II · Zydus Pharmaceuticals (USA) Inc
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Lots: Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Erythromycin: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA212693
- On the market since
- Jun 30, 2023
- Package NDCs
70710-1048-170710-1048-370710-1048-5- Official label
- DailyMed (National Library of Medicine), updated Mar 20, 2024
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