Why it was recalled
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Product description
Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01
Lot numbers, UPCs & expiration codes
Lot #: HL06015, HL06115, Exp. 10/2017
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1439-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 25, 2017
- FDA report date
- Jul 10, 2019
- Quantity
- 19176 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1439-2019, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83137
- Address
- 50 Horseblock Rd
- Code information
- Lot #: HL06015, HL06115, Exp. 10/2017
- Postal code
- 11719-9509
- Report date
- Jul 10, 2019
- Product type
- Drugs
- Recall number
- D-1439-2019
- Classification
- Class III
- Recalling firm
- Amneal Pharmaceuticals, Inc.
- Product quantity
- 19176 units
- Termination date
- Aug 8, 2019
- Reason for recall
- Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Sep 25, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 1, 2019