Drug product
Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28
D-0007-2026
Product summary
- Firm
- AvKARE
- Event
- Event 97542
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2192 cartons
- Official record key
drug-enforcement:D-0007-2026
Official wording
Reason: Failed Content Uniformity Specifications
Code information: Lot # LF41138A; Exp 06/30/2027
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Failed Content Uniformity Specifications