Why it was recalled
cGMP Deviations: lack of quality assurance at the API manufacturer.
Product description
Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3) and d) 100 G bottle (NDC 51552-1392-5), Rx only, Distributed by Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967
Lot numbers, UPCs & expiration codes
Lot #, Expiration Date: a) 1 G bottle: 16F23-U05-033657, Exp. 5/26/2017. b) 5 G bottle: 16F23-U05-033656, Exp. 5/26/2018; 17C02-U02-035890, Exp. 1/19/2019. c) 25 G bottle: 16F23-U05-033655, Exp. 5/26/2018; 17C02-U02-035887, Exp. 1/19/2019. d) 100 G bottle: 17C02-U02-035888, Exp. 1/19/2019
Where it was sold
Nationwide in USA
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-0079-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 25, 2017
- FDA report date
- Nov 22, 2017
- Quantity
- 934 grams
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fagron, Inc
Original FDA data
Every field from FDA enforcement report D-0079-2018, exactly as published.
Show all FDA fields
- City
- Saint Paul
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 78402
- Address
- 2400 Pilot Knob Rd
- Code information
- Lot #, Expiration Date: a) 1 G bottle: 16F23-U05-033657, Exp. 5/26/2017. b) 5 G bottle: 16F23-U05-033656, Exp. 5/26/2018; 17C02-U02-035890, Exp. 1/19/2019. c) 25 G bottle: 16F23-U05-033655, Exp. 5/26/2018; 17C02-U02-035887, Exp. 1/19/2019. d) 100 G bottle: 17C02-U02-035888, Exp. 1/19/2019
- Postal code
- 55120-1118
- Report date
- Nov 22, 2017
- Product type
- Drugs
- Recall number
- D-0079-2018
- Classification
- Class II
- Recalling firm
- Fagron, Inc
- Product quantity
- 934 grams
- Termination date
- May 11, 2018
- Reason for recall
- cGMP Deviations: lack of quality assurance at the API manufacturer.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3) and d) 100 G bottle (NDC 51552-1392-5), Rx only, Distributed by Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967
- Distribution pattern
- Nationwide in USA
- Recall initiation date
- Oct 25, 2017
- Initial firm notification
- Telephone
- Center classification date
- Nov 14, 2017