FDA Drug recall D-0533-2018
Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2)
- FDA Drug
- Class II
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2) 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-0533-2018 |
| 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
Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), 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) 070717-2, Exp. 05/31/2020; b) 070717-1, Exp. 05/31/2020; c) 070717-1, Exp. 05/31/2020; d) 070717-1, Exp. 05/31/2020. |
|---|
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-0533-2018%22
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