Why it was recalled
Failed Impurities/Degradation Specifications.
Product description
Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8
Lot numbers, UPCs & expiration codes
Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25
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-0543-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- May 16, 2024
- FDA report date
- Jun 12, 2024
- Quantity
- 13,440 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0543-2024, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94649
- Address
- 73 Route 31 N
- Code information
- Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25
- Postal code
- 08534-3601
- Report date
- Jun 12, 2024
- Product type
- Drugs
- Recall number
- D-0543-2024
- Classification
- Class III
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 13,440 units
- Reason for recall
- Failed Impurities/Degradation Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 16, 2024
- Initial firm notification
- Letter
- Center classification date
- Jun 6, 2024