Esterified Estrogens & Methyltestosterone Tablets recall: Subpotent
Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01
Why was Esterified Estrogens & Methyltestosterone Tablets recalled?
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
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?
Lot #: HL05715, HL05815, Exp. 11/2017
- Product
- Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01
- Recalling firm
- Amneal Pharmaceuticals, Inc.
- Quantity
- 19104 units
- Distribution
- Nationwide within the United States
- Recall date
- July 10, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)