Femtrace 0.45 mg recall: Impurity Out of Spec
Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner…
Why was Femtrace 0.45 mg recalled?
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
0.45 mg: 505969A
- Product
- Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner…
- Recalling firm
- Warner Chilcott Company LLC
- Quantity
- 3155 bottles
- Distribution
- US Nationwide
- Recall date
- February 6, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)