Why it was recalled
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Product description
ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261
Lot numbers, UPCs & expiration codes
a) 129669/C, 129669/F, 129669/H, 129669/J, 130941/B 130941/D, 130941/F, 136108/B, 139091/B; b) 129669/B, 129669/E, 130941/A, 130941/C, 130941/E,130941/G, 136108/A,
Where it was sold
Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
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-0666-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 3, 2017
- FDA report date
- Apr 19, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medisca, Inc.
Original FDA data
Every field from FDA enforcement report D-0666-2017, exactly as published.
Show all FDA fields
- City
- Plattsburgh
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 76873
- Address
- 661 State Route 3 Unit C
- Code information
- a) 129669/C, 129669/F, 129669/H, 129669/J, 130941/B 130941/D, 130941/F, 136108/B, 139091/B; b) 129669/B, 129669/E, 130941/A, 130941/C, 130941/E,130941/G, 136108/A,
- Postal code
- 12901-6531
- Report date
- Apr 19, 2017
- Product type
- Drugs
- Recall number
- D-0666-2017
- Classification
- Class II
- Recalling firm
- Medisca, Inc.
- Termination date
- Jun 18, 2019
- Reason for recall
- cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261
- Distribution pattern
- Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
- Recall initiation date
- Apr 3, 2017
- Initial firm notification
- Letter
- Center classification date
- Apr 12, 2017