Fagron, Inc Recall: Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC:
Fagron, Inc Recall: Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Fagron, Inc; Product: Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25
| Recalling firm | Fagron, Inc |
|---|---|
| Product | Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estrone USP, For Prescription Compounding, packaged in a) 1 G bottle (NDC 52372-9494-01), b) 5 G bottle (NDC 52372-9494-05), c) 25 G bottle (NDC 52372-9494-03), d) 100 G bottle ( NDC 52372-9494-02), Rx only, Distributed by FREEDOM 801 W. New Orleans St. Broken Arrow, OK 74011 Tel. (877) 839 |
| Reason for recall | cGMP Deviations: lack of quality assurance at the API manufacturer. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide in US and PR and Australia |
| Recall initiated | 20170406 |
| Recall number | D-0792-2017 |
| Category | drug |
| State | MN |
| Country | United States |
$29/mo
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