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Safecor Health, LLC: Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by:

DrugsSource: FDA (drug) · Date: 2026-09-23

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Safecor Health, LLC
Product
Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16
Reason / hazard
Failed Stability Specifications
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA.
Recall initiated
2026-08-13
Code info
Lot#:26220866; Exp :06/18/2027 Lot#:25321477; Exp :0/18/2026 Lot#:25471651; Exp :12/01/2026 Lot#:25500133; Exp :12/19/2026 Lot#:26161398; Exp :12/31/2026 Lot#:26170946; Exp :05/15/2027 Lot#:26240033; Exp :05/31/2027
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Woburn
State
MA
Country
United States
Event id
99654
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