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
Reported: November 22, 2017 Initiated: October 25, 2017 #D-0079-2018
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
Reason for Recall
cGMP Deviations: lack of quality assurance at the API manufacturer.
Details
- Recalling Firm
- Fagron, Inc
- Units Affected
- 934 grams
- Distribution
- Nationwide in USA
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fagron, Inc. Units affected: 934 grams.
Why was this product recalled? ▼
cGMP Deviations: lack of quality assurance at the API manufacturer.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 22, 2017. Severity: Moderate. Recall number: D-0079-2018.
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