Drug product
Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
D-141-12013
Product summary
- Event
- Event 64014
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5439 bottles
- Official record key
drug-enforcement:D-141-12013
Official wording
Reason: Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Code information: 0.9 mg: 512348A
Distribution pattern: US Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specifications