Why it was recalled
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Product description
ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732
Lot numbers, UPCs & expiration codes
a) 126317/D,126317/F,127288/C, 127296/D, 136212/C, 137155/C,137156/C, 138638/C,138646/B, 138646/E, 138646/I b) 126317/C, 126317/E, 127288/B, 127296/C, 136212/B, 137155/B, 137156/B, 138638/B, 138646/A, 138646/D,138646/H c) 126317/B,127288/A,127296/B, 136212/A, 137155/A, 137156/A,138638/A, 138646/C, 138646/G, 141219/A d) 126317/A, 127296/A, 138646/F
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-0663-2017
- 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-0663-2017, 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) 126317/D,126317/F,127288/C, 127296/D, 136212/C, 137155/C,137156/C, 138638/C,138646/B, 138646/E, 138646/I b) 126317/C, 126317/E, 127288/B, 127296/C, 136212/B, 137155/B, 137156/B, 138638/B, 138646/A, 138646/D,138646/H c) 126317/B,127288/A,127296/B, 136212/A, 137155/A, 137156/A,138638/A, 138646/C, 138646/G, 141219/A d) 126317/A, 127296/A, 138646/F
- Postal code
- 12901-6531
- Report date
- Apr 19, 2017
- Product type
- Drugs
- Recall number
- D-0663-2017
- 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
- ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732
- 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