Drug product
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
D-0543-2026
Product summary
- Event
- Event 98947
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3964 Cartons
- Official record key
drug-enforcement:D-0543-2026
Official wording
Reason: Defective Container; packets were found to be either empty or partially full.
Code information: Lot M251109, exp Nov 2027
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Defective Container; packets were found to be either empty or partially full.