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:
Read the official notice at FDA (drug) →
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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