FDA Drug recall D-0492-2018
Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4)
- FDA Drug
- Class II
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4) by American Pharmaceutical Ingredients, citing CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0492-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-09 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Pharmaceutical Ingredients |
| Distribution | US |
Product
Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Reason
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Identifiers
| code_info | Lot #: a) 051115-1, Exp. 4/30/2020; 081017-1, exp 11/30/2021; 122216-1,122216-2, Exp. 12/31/2020; b) 041017-1, Exp. 11/…Lot #: a) 051115-1, Exp. 4/30/2020; 081017-1, exp 11/30/2021; 122216-1,122216-2, Exp. 12/31/2020; b) 041017-1, Exp. 11/30/2021; 051115-1, Exp. 4/30/2020; 081017-1, exp 11/30/2021; c) 041017-1, 041017-2, Exp. 11/30/2021; 122216-1, 122216-2, exp. 12/31/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0492-2018%22
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